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

Catalog Number	05060303001
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a patient id that was scanned by the accu-chek inform ii meter + rf as a different patient id.The patient id scanned was (b)(6) and the patient id displayed in the cobas infinity as (b)(6) and was flagged as not matching.The same issue occurred on (b)(6)2025 with the same patient id on the same meter but with a different operator.The incorrect id was a legitimate patient id in their system, however, that patient was not hospitalized at the time of the event.There was no harm to any patient related to the event.
Additional Manufacturer Narrative
The investigation is ongoing.
Additional Manufacturer Narrative
The customer meter barcode functionality was tested using sample barcodes.1d and 2d barcodes of various symbologies were scanned using the customer meter multiple times each.All barcodes were scanned correctly.No issue was found with the barcode scanning function of the meter.The device was disassembled for further investigations.The visual inspection of the electronic parts showed no abnormalities, and no contamination was found.The alleged malfunction was not reproducible with the customer meter.The product performed according to the specifications.As no problem was found with the meter, the cause can be narrowed down to the customer's barcode or other factors not caused by the customer's instrument.Since the customer was unable to provide any samples of their barcodes to test for barcode quality, further investigation cannot be completed.The investigation determined that 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21593215
• Report Number: 1823260-2025-00727
• Device Sequence Number: 8331299
• Product Code: LFR
• UDI-Device Identifier: 04015630925469
• UDI-Public: 04015630925469
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 06/02/2025

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/20/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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