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

Catalog Number	05060303001
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of an instance of a patient mismatch while using the accu-chek inform ii meter.At 5:03 pm, a glucose test was performed on patient a at bed 20 (patient id: (b)(6)) using the meter, resulting in 11.3 mmol/l.The result was tagged to the correct patient id in the meter and transmitted correctly.At 5:05 pm, a glucose test was performed on patient b at bed 22 (patient id: (b)(6)) using the same meter, resulting in 6.2 mmol/l.The staff checked the meter and found that the result was tagged incorrectly to patient a's id (b)(6) in the meter and transmitted under id (b)(6).The 2 patients were in the same room, and both tests were performed back-to-back by the same staff member.
Additional Manufacturer Narrative
The staff member was interviewed after the incident on the workflow and was not certain that they verified the information in the patient confirmation page before proceeding with the test.The investigation is ongoing.
Additional Manufacturer Narrative
Medwatch fields a3a, b7, and d9 were updated.The investigation is ongoing.
Additional Manufacturer Narrative
Pictures of the barcodes for each patient were reviewed: id 558f (patient a) and id 340g (patient b).The misaligned ids are not similar to each other, and the barcodes are not optically similar.The barcode quality for patient a appears to be less than the quality of the barcode for patient b.The barcode for patient a has lines across the barcode, and the black color has less intensity.Both barcodes were scanned with no issues.The customer's allegation was not reproduced by the investigation.Several potential root causes, such as errors in programming, barcode decoding, or hardware issues, as well as communication errors, were investigated.All of these potential causes were excluded.A meter software issue was not identified.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 23647443
• Report Number: 1823260-2025-04842
• Device Sequence Number: 21322529
• 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,Followup
• Report Date (Section B): 03/20/2026

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/02/2025
• Supplement Date Received by Manufacturer: 02/01/2026; 03/04/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 02/26/2026; 03/20/2026
• 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: Male