Accu-Chek Inform II Base Unit Light 08376824190Recalls & reported problems
Roche Diagnostics GmbH · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613336155318), received between Nov 28, 2022 and Nov 28, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Charging Problem” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K121679); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Charging Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 28, 2022Charging Problem; Charging Problem
WE RECEIVED AN ALLEGATION OF A BLACKENED LEFT CHARGING CONTACT OF THE ACCU-CHEK INFORM II METER CHARGING BASE. THE REPORTER ALSO STATED THAT THE BASE NO LONGER CHARGES. THERE WAS NO MELTED PLASTIC OBSERVED ON THE BASE. THE REPORTER CONFIRMED NONE OF THE METERS WERE BURNT AND THAT THERE WAS NO FIRE OR SERIOUS INJURY THAT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15872451 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K121679. One submission often covers many models, so check the product and lot details in each record.
- Z-2354-2021 · Jul 28, 2021 · Open, ClassifiedAccu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001
- Z-1172-2016 · Feb 11, 2016 · TerminatedAccu-Chek Inform II Base Unit as a part of the Accu-Chek Inform II Blood Glucose Monitoring System Accu-Chek inform II Blood Glucose Monitoring System is intended for testing outsi
- Z-1113-2013 · Mar 6, 2013 · TerminatedACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Used with the ACCU-CHEK Inform II System to quantitatively measure glucose (sugar).
Other SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER devices
- OneTouch Verio Flex 023-271LifeScan Europe GmbH · SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER3,703 reports
- FreeStyle Libre 2 71953Abbott Diabetes Care Inc · System, test, blood glucose, over the counter2 recalls1 death3,286 reports
- OneTouch Ultra2 021-105LifeScan U.S. LLC · SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER1,731 reports
- Omnipod DASH PDM PDM-USA1-D001-MG-USA1Insulet Corporation · System, Test, Blood Glucose, Over The Counter1 recall10 deaths1,129 reports
- Omnipod UST400Insulet Corporation · System, Test, Blood Glucose, Over The Counter12 deaths816 reports
- TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER - NOT FOR RETAIL SALETrividia Health, Inc. · System, Test, Blood Glucose, Over The Counter418 reports
- FreeStyle Freedom Lite 70923-70Abbott Diabetes Care Inc · SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER378 reports
- FreeStyle Lite 70829-70Abbott Diabetes Care Inc · SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER378 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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