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	09/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The meters and the respective patient wristbands were requested to be returned for further investigation.The investigation is ongoing.
Event or Problem Description
There was an allegation of two instances of a patient mismatch while using the accu-chek inform ii meters.Event 1 (b)(6) 2025): at 11:35 am, a glucose test was performed on patient a (id (b)(6) using meter (b)(6).Patient a's id was correctly scanned, and a result of 9.1 mmol/l was obtained on the meter.This result was transmitted and reported under the correct patient id.At 11:39 am, a glucose test was performed on patient b (id (b)(6) using meter (b)(6).Patient b's id was correctly scanned, and a result of 5.5 mmol/l was obtained on the meter.When this result was transmitted, it was somehow tagged to patient a (id (b)(6).The staff checked the meter and found that the results (9.1 mmol/l and 5.5 mmol/l) were both tagged to patient a (id (b)(6).No result for patient b (id (b)(6) could be found on the meter.Event 2 (26-sep-2025): at 7:12 pm, a glucose test was performed on patient c (id (b)(6) using meter (b)(6).Patient c's id was correctly scanned, and a result of 12.7 mmol/l was obtained on the meter.This result was transmitted and reported under the correct patient id.At 7:15 pm, a glucose test was performed on patient d (id (b)(6) using meter (b)(6).Patient d's id was correctly scanned, and a result of 6.3 mmol/l was obtained on the meter.When this result was transmitted, it was somehow tagged to patient c (id (b)(6).The staff checked the meter and found that the results (12.7 mmol/l and 6.3 mmol/l) were both tagged to patient c (id (b)(6).No result for patient d (id (b)(6) could be found on the meter.
Additional Manufacturer Narrative
Medwatch field d9 was updated.Meter serial number (b)(6) was received for investigation.The reported issue could not be reproduced during internal testing.All results were correctly tagged to their corresponding patient identifiers.The meter error log did not reveal any relevant information.As the issue could not be replicated, the investigation was unable to determine a specific root cause.No product problem or malfunction was found.

• 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: 23509996
• Report Number: 1823260-2025-04561
• Device Sequence Number: 21258841
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 11/10/2025
• 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