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	08/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
We received an allegation of a patient mismatch from a customer using the accu-chek inform ii meter.At 7:52 am, patient a was tested and had a result of 7.9 mmol/l.The patient's barcoded wrist tag was correctly scanned, and the correct result was transmitted to the laboratory information system (lis).At 7:58 am, patient b was tested and had a result of 14.9 mmol/l.The patient's barcoded wrist tag was correctly scanned, but the result was incorrectly transmitted to the lis; the result was tagged to patient a.The customer checked the meter and found the results of 7.9 mmol/l and 14.9 mmol/l tagged to patient a.The result of patient b could not be found on the meter.The staff confirmed that the result does not belong to patient a, as patient b is diabetic and requires insulin daily.The customer ruled out incorrect barcodes and scanning and confirmed that they followed the correct workflow.
Additional Manufacturer Narrative
The investigation analyzed the accu-chek inform ii meter + rf meter's error log and an example of the customer's patient wrist band.The investigation determined that the event was consistent with a handling issue in the creation of the patient wrist bands with different barcode contents.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
• MDR Report Key: 23096551
• Report Number: 1823260-2025-03189
• Device Sequence Number: 18517629
• 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): 11/04/2025

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: 08/27/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 11/04/2025
• 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