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	07/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a software issue with an accu-chek inform ii meter + rf.For 1 patient, the date of birth on the meter did not correspond to the date of birth that was used when the patient was registered.The patient was admitted through the emergency room as an unknown patient with a date of birth of "(b)(6) 1900." it is the emergency room¿s procedure to use the year 1900 for unknown patients, as unknown patients should be 125 years old.The clerk entering the date uses various months/days to create these dates.The date of birth in the hospital system and the cobas infinity software correspond to the date of birth of "(b)(6) 1900" used at registration.The patient¿s date of birth on the inform meter is showing as "(b)(6) 1969." the date of birth cannot be manipulated at the meter level.
Additional Manufacturer Narrative
The meter was requested for investigation.
Additional Manufacturer Narrative
The customer did not return the meter for investigation.As no product was returned, a specific root cause could not be determined.
Additional Manufacturer Narrative
The meter was received for investigation.The meter data was read out, and no patient was found with a date of birth of "(b)(6)" or the year "(b)(6)".The meter patient id confirmation was enabled and set to "name/dob" and patient id validation was set to "length" therefore, all available patient id information for the selected patient is displayed on the patient test screen.Additional patient identifiers, such as name and date of birth can help verify patient identity.If no dob is available, a dash (-) is shown instead.The investigation determined that the issue could not be traced to the meter itself.No logs were obtained at the time of the event, and no further data can be provided.No product issue was found.Medwatch sections d9 and h3 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: 22688903
• Report Number: 1823260-2025-02375
• Device Sequence Number: 12838838
• Product Code: LFR
• UDI-Device Identifier: 04015630925469
• UDI-Public: 04015630925469
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 01/13/2026

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/11/2025
• Supplement Date Received by Manufacturer: 09/11/2025; 12/19/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 09/25/2025; 01/13/2026
• 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