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	03/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
The initial reporter stated there was an issue with an alleged patient result mismatch when using accu-chek inform ii meter serial number (b)(6).At 7:04 a.M., operator a performed a glucose test on patient a (with identifier ending with (b)(6) with the meter.Patient an id was correctly scanned and resulted 11.0 mmol/l on the meter.This result was transmitted to the customer's laboratory information system (lis) under the correct patient id (id ending with (b)(6).At 7:07 a.M., operator b performed a glucose test on patient b (id ending with (b)(6) using the meter.Patient b id was correctly scanned and resulted 7.7 mmol/l on the meter.When this result was transmitted to the lis, it was somehow tagged to patient a's id (ending with (b)(6) instead.Operator b checked on the meter and found that 2 results (11.0 mmol/l and 7.7 mmol/l) were both tagged to patient a's id (ending with (b)(6).The result for patient b (id ending with (b)(6) could not be found on the meter.The nurse in charge confirmed that the result of 7.7 mmol/l does not belong to patient a as the expected glucose result for patient a is around 10-11 mmol/l and a decrease of 3.3 mmol/l within 3 minutes was deemed not possible.Investigations performed at the customer site ruled out any possibility of a user error such as accidentally scanning the wrong patient id.The patients were in different rooms and different operators handle the different rooms.The meter was logged out before operator b performed glucose testing on patient b.Operator b scanned the barcode on the patient's wrist tag and reflected as patient b's id.Operator b confirmed and verified that the id belonged to patient b before proceeding with the test.Testing was repeated on patient b using the same workflow and the result transmitted correctly to the lis as patient b's id.
Additional Manufacturer Narrative
The investigation did not identify a product issue.Several potential root causes such as communication issues, programming issues, decoding issues, production issues, and handling issues were analyzed.All root causes are very unlikely and most can be ruled out.The most possible root cause is a handling issue in creation of the wrist bands, having different barcode contents.

• 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: 22150471
• Report Number: 1823260-2025-01737
• Device Sequence Number: 12724993
• 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): 10/23/2025

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: 05/16/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 10/23/2025
• 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