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	11/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
The initial reporter alleged there was an issue with accu-chek inform ii meter serial numbers (b)(6).With each meter, the customer alleges they have had an issue where patient results were tagged to the wrong patient identifier.On (b)(6) 2025 at 07:04 a.M., a glucose test was performed on patient a (id (b)(6) using meter (b)(6).Patient a's id was correctly scanned and resulted in a value of 13.4 mmol/l on the meter.This result was transmitted to the customer's middleware system and laboratory information system (lis) under the correct patient id (id ending with (b)(6).On (b)(6) 2025 at 07:07 a.M., a glucose test was performed on patient b using meter (b)(6).Patient b (id (b)(6) was correctly scanned and resulted in a value of 4.3 mmol/l on the meter.When this result was transmitted to the customer's middleware and lis, it was somehow tagged to patient a (id (b)(6) instead.The staff checked the meter and found the 2 results (13.4 mmol/l and 3.2 mmol/l) were both tagged to patient a (id (b)(6).The result for patient b (id (b)(6) could not be found on the meter.Patients a and b were in different rooms.There was another nurse that witnessed the staff performing the test on the patient and confirmed that the correct patient id was scanned.The patient's wristband was re-checked when the customer discovered the issue and the correct patient details were reflected in the meter software.On (b)(6) 2025 at 07:34 a.M., a glucose test was performed on patient c (id (b)(6) using meter (b)(6).Patient c's id was correctly scanned and resulted in a value of 9.2 mmol/l on the meter.This result was transmitted to the customer's middleware and lis under the correct patient id (id ending with (b)(6).On (b)(6) 2025 at 07:35 a.M., a glucose test was performed on patient d using meter (b)(6).Patient d (id (b)(6) was correctly scanned and resulted in a value of 13.0 mmol/l on the meter.However, the performing staff noticed that the patient identifiers reflected as another patient's name at the results page of the meter software.The staff is not sure at which point of time that the patient name/id started to reflect incorrectly.The meter reflected both results (9.2 mmol/l and 13.0 mmol/l) were tagged to patient c id (b)(6).
Additional Manufacturer Narrative
Investigations of provided data and material can exclude a meter software defect.Barcode misreading/decoding errors, communication errors, or hardware issues as well as issues in the meter production can be excluded.The investigation could not identify a product problem.The cause of the event could not be determined.The issue is consistent with a handling issue.

• 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: 23821768
• Report Number: 1823260-2025-05141
• Device Sequence Number: 21323086
• 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): 03/23/2026

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): Initial
• Initial Date Received by Manufacturer: 11/28/2025
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 03/23/2026
• 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