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	01/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of an accu-chek inform ii meter + rf that incorrectly scanned a patient id and then flagged it as not being a valid patient id.The customer completed testing without a patient name or birthday, and the results did not go into a medical record as they were flagged as not being a valid patient.
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.No product issue was found with the customer meter.

• 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: 21874503
• Report Number: 1823260-2025-01204
• Device Sequence Number: 8641454
• 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): 05/30/2025

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: 03/28/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 05/30/2025
• 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