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	10/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation of questionable glucose results for one patient tested with the accu-chek inform ii meter + rf.The first meter result was 8 mmol/l.The second meter result was 4 mmol/l.The time interval between the tests was less than fifteen minutes.
Additional Manufacturer Narrative
The accu-chek inform ii meter + rf meter serial number is (b)(6).The test strips were requested for investigation but have not been received.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 the results have passed the internal inspection.
Additional Manufacturer Narrative
Medwatch sections d.Device identification, d.Manufacturer info, g contact office-manufacturing site (continued g1), and medwatch fields d9 device available for evaluation and g4 pma / 510k (premarket numbers) updated.The accu-chek inform ii meter + rf was received for investigation.The investigation noted that the meter was heavily contaminated with control solution in the test strip port, battery compartment, and on the scanner window.Product labeling states, "when applying the control solution, position the meter so that the test strip port is always higher or on the same level as the control solution.This prevents any excess solution from flowing down the strip and entering the meter." the investigation determined that customer mishandling had caused the event.The investigation did not identify a product problem.

• 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 46250-0457
• MDR Report Key: 23520730
• Report Number: 1823260-2025-04580
• Device Sequence Number: 21265622
• Product Code: LFR
• UDI-Device Identifier: 04015630925469
• UDI-Public: 04015630925469
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 02/13/2026

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: 05060303001
• Device Lot Number: 671749
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 02/13/2026
• 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 Sex: Unknown