ACCU-CHEK GUIDE · recalls, adverse events, clearances

Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history

Initiated	Recall #	Class	Status	Reason	Quantity	Link basis
2024-05-13	Z-2174-2024	Class II	Open, Classified	The reason for recall is the meters may show an incorrect measurement unit (mmol/L rather than mg/dL) and may result in the wrong unit of measure. Which may subsequently cause an error in interpreting a result as approximately 18 times lower that the actual blood glucose. Potential immediate health consequences of the glucose meter providing a reading in the wrong units of measurement (UOM) may result in inappropriate rescue therapy for presumed hypoglycemia including urgent and repeat administration of carbohydrates. This in turn could lead to frequent episodes of hyperglycemia which is unrecognized and undertreated.Long range consequences of continued use of the affected meters could include mismanagement of the patient s diabetes for longer periods of time potentially resulting in a major health event (in general persistent and/or severe hyperglycemia) that may lead them to seek medical attention, and depending on the duration of hyperglycemia, could contribute to the development of microvascular (i.e., retinopathy, neuropathy, nephropathy) and/or macrovascular (i.e., myocardial infarction, ischemic stroke) complications of diabetes and could lead to fetal damage (abnormal fetal growth and altered organ development and maturation, fetal hypoxemia, spontaneous abortion, and congenital anomalies) in pregnant women. This issue was identified by three initial consumer complaints, with reports that the meters were presenting the incorrect unit of measure.Distribution: Nationwide and Worldwide	48 units	clearance family
2019-09-30	Z-0747-2020	Class II	Terminated	Potential power issues with the Accu-Chek Guide Blood Glucose Monitoring System.Distribution: US Nationwide distribution and countries of AR, AT, AU, BE, BR, CA, CH, CL, DE, DK, EC, ES, FI, FR, GB, GR, HK, HR, ID, IN, IT, JP, KR, LB, LT, LU, MM, MY, NL, NO, PH, PK, PT, SE, SG, TH, TW, ZA.	318,678	clearance family

Regulatory clearances

510(k)K160944Substantially equivalent (SESE) · 2016-08-31clearance family

Predicate lineage

K160944

Cited as predicate by: K203711, K213131

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2023-11-30	NAI	No action indicated	Roche Molecular Systems, Inc.	0
2022-12-07	NAI	No action indicated	Roche Diagnostics Operations, Inc.	0
2022-09-23	NAI	No action indicated	Ventana Medical Systems, Inc.	0
2022-09-15	NAI	No action indicated	Ventana Medical Systems, Inc.	0
2021-07-29	NAI	No action indicated	Ventana Medical Systems, Inc.	0
2020-02-26	NAI	No action indicated	Ventana Medical Systems, Inc.	0
2019-08-29	VAI	Voluntary action indicated	Roche Diagnostics GmbH	0
2019-08-14	NAI	No action indicated	Ventana Medical Systems, Inc.	0
2019-07-25	VAI	Voluntary action indicated	Roche Diabetes Care, Inc.	3
2019-06-27	VAI	Voluntary action indicated	Roche Diagnostics Operations, Inc.	1
2018-04-19	NAI	No action indicated	Roche Diagnostics GmbH	0
2018-04-12	NAI	No action indicated	Roche Diagnostics GmbH	0
2017-07-24	NAI	No action indicated	Roche Molecular Systems, Inc.	0
2017-07-13	NAI	No action indicated	Ventana Medical Systems, Inc.	0
2017-02-27	NAI	No action indicated	Roche Molecular Systems, Inc.	0
2017-02-02	VAI	Voluntary action indicated	Roche Diabetes Care GmbH	1
2016-11-18	NAI	No action indicated	Roche Diagnostics GmbH	0
2016-10-14	NAI	No action indicated	Roche Diagnostics Operations, Inc.	0
2016-09-01	NAI	No action indicated	Roche Molecular Systems, Inc.	0
2016-08-15	VAI	Voluntary action indicated	Roche Diagnostics Operations, Inc.	1

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