MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ACCU-CHEK INFORM II TEST STRIPS; BLOOD GLUCOSE MONITORING TEST STRIPS

Catalog Number	05942861001
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The accu-chek inform ii meter + rf (meter a) serial number is (b)(6).The accu-chek inform ii meter + rf (meter b) serial number is (b)(6).The product has been requested for investigation; however, the product has not been received at this time.If the product is returned in the future, a follow-up report will be submitted.On a regular basis accu-chek inform strips of lots currently valid in the market are tested as part of routine retention testing and results have passed the internal inspection.
Event or Problem Description
There was an allegation of a questionable glucose result using the accu-chek inform ii test strips from two accu-chek inform ii meters + rf for one patient.The initial result from meter a at 12:58 was 67 mg/dl.The second result from meter a at 12:59 was 60 mg/dl.The third result from meter a at 14:01 was 27 mg/dl.The fourth result from meter a at 14:03 was "lo", stating that the result was less than 20 mg/dl.A result from meter b at 14:09 was 108 mg/dl.A second result from meter b at 14:10 was 120 mg/dl.A venous sample was collected at 14:50, and the result was 142 mg/dl.A second venous sample was collected at 15:13, and the result was 132 mg/dl.The patient was given d50 as a result of the initial questionable result of 67 mg/dl.It was verified that the patient was not adversely affected by the treatment.
Additional Manufacturer Narrative
No product was returned for investigation.There is no information provided that would point to a cause for the discrepancy.As no customer material was received in order to carry out a substantial investigation, this global investigation will be closed as no product issue found.

• Brand Name: ACCU-CHEK INFORM II TEST STRIPS
• Common Device Name: BLOOD GLUCOSE MONITORING TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 24210550
• Report Number: 1823260-2026-00315
• Device Sequence Number: 9635757
• Product Code: LFR
• UDI-Device Identifier: 00365702428102
• UDI-Public: 00365702428102
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K121679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 05942861001
• Device Lot Number: 671702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2026
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Sex: Female