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

Catalog Number	05060303001
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The test strip lot number and expiration date were not provided.Quality controls were performed prior to the testing and were valid.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 and strips have been requested for return.The strips were not available to be returned.The product has not been received at this time.If the product is returned in the future, a follow-up report will be submitted.
Event or Problem Description
There was an allegation of questionable glucose results from the accu-chek inform ii meter.On (b)(6) 2026 at 05:54, a glucose test was performed prior to the planned oral glucose tolerance test (ogtt) test with a result of 175 mg/dl.The patient reported that she had never had such a high glucose level before.Two follow-up measurements were taken from the finger.At 05:56, the result was 87 mg/dl, and at 05:58, the result was 127 mg/dl.A sample was taken from a fluoride plasma blood sample, and the result was 95.7 mg/dl.
Additional Manufacturer Narrative
The test strip lot number was 671404.The customer¿s returned meter was tested with retention strips and retention controls.No damage or contamination observed.Control ranges: level 1: 100-136 mg/dl.Level 2: 261-353 mg/dl.Results: level 1: 112, 112, 113 mg/dl.Level 2: 292, 296, 292 mg/dl.All returned results are within the acceptable range.The alleged issue could not be reproduced.No product issue was found.Medwatch fields d9 device available for evaluation and d9 date device returned were updated.

• 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: 24391799
• Report Number: 1823260-2026-00601
• Device Sequence Number: 10279112
• Product Code: LFR
• UDI-Device Identifier: 04015630925469
• UDI-Public: 04015630925469
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2026

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): Initial
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 03/20/2026
• 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: 20 YR
• Patient Sex: Female