MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ACCU-CHEK INFORM II METER + RF; BLOOD GLUCOSE MONITORING DEVICE

Catalog Number	05060303001
Medical Device Problem Codes	Product Quality Problem (1506); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter alleged a questionable result from the accu-chek inform ii meter.While reviewing results from the meter, the customer observed a result of 229 mg/dl and a result of 109 mg/dl.The customer was adamant that the result of 229 mg/dl appeared on its own after the strip had been inserted and alleged that the result appeared when no sample had been applied.She alleged that the result of 109 mg/dl was the only actual patient result.This result was not questioned.The result of 229 mg/dl was obtained at 6:25 am, and the result of 109 mg/dl was obtained at 6:26 am.
Additional Manufacturer Narrative
The test strip lot number was 671669.The expiration date was not provided.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.The meter was requested for return.The product has not been received at this time.If the product is returned in the future, a follow-up report will be submitted.
Additional Manufacturer Narrative
Medwatch fields d9 device available for evaluation and d9 date device returned were updated.The customer's meter was received for investigation and was tested using retention test strips and quality contol materials.Control ranges: level 1: 30-60 mg/dl, level 2: 261-353 mg/dl.Results: level 1: 43, 43, and 42 mg/dl.Level 2: 295, 296, and 297 mg/dl.All returned results are within the acceptable range.The log file did not indicate any hardware or software issues.The meter was disassembled for further investigation.No damage or contamination observed.The alleged issue could not be reproduced.No product issue was found.

• Brand Name: ACCU-CHEK INFORM II METER + RF
• Common Device Name: BLOOD GLUCOSE MONITORING DEVICE
• 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: 24636923
• Report Number: 1823260-2026-00987
• Device Sequence Number: 21272410
• Product Code: LFR
• UDI-Device Identifier: 04015630925469
• UDI-Public: 04015630925469
• 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): 04/29/2026

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: 05060303001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/26/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 04/29/2026
• 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 Sex: Unknown