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

Catalog Number	05060303001
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user rejected the 8.2 mmol/l result in navify poc.The investigation is ongoing.
Event or Problem Description
There was an allegation of an instance of a patient mismatch while using the accu-chek inform ii meter.At 7:08 am, a glucose test was performed on patient a using the meter, resulting in 7.5 mmol/l.The result was tagged to the correct patient id in the meter and transmitted correctly to navify point of care (poc).At 7:12 am, a glucose test was performed on patient b using the same meter, resulting in 8.2 mmol/l.The transmitted data in navify poc reflected that the result was tagged incorrectly to patient a's id.The staff checked the meter and found that both 8.2 mmol/l and 7.5 mmol/l results were tagged to patient a's id, while patient b's result with patient b's id cannot be found in the meter.
Additional Manufacturer Narrative
The pictures of the reprinted wristbands for both patients were provided for investigation, and the investigation results were as follows: the wristbands contained multiple quick response (qr) codes with the same patient id.Qr codes ensure correct readings by utilising checksums.The codes might have been a bit further apart for scanning the patient ids.The qr codes for patient a and patient b were not visually similar to each other.Without the original barcode wristbands or example wristbands, a more detailed barcode analysis can't be provided, as the quality changes when the photo was taken and also when printed.The laboratory's point-of-care coordinator (pocc) performed a re-test and confirmed that the correct id was read on the meter.No meter issue was found.The investigation did not identify a product problem.Although the cause of the event could not be determined, it was consistent with a handling issue.

• 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: 23741139
• Report Number: 1823260-2025-04980
• Device Sequence Number: 10150581
• Product Code: LFR
• UDI-Device Identifier: 04015630925469
• UDI-Public: 04015630925469
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 03/27/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2025
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 03/30/2026
• 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