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

Catalog Number	04882458001
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The meter was returned for an investigation.Replacement product was sent.The investigation is ongoing.
Event or Problem Description
There was an allegation of an incorrect date being transmitted from the accu-chek inform ii meter to the cobas infinity system.On (b)(6) 2022, the patient was measured with the accu-chek inform ii meter.The customer reviewed the glucose result within the infinity system and the date of the result stated (b)(6) 2022.The meter was reset and restarted, the customer confirmed the value to the cobas infinity system was (b)(6) 2022.The customer confirmed the patient's result was from (b)(6) 2022.
Additional Manufacturer Narrative
The investigation found one patient sample had the incorrect time stored.It was confirmed by the customer that the time and date were not changed.The investigation found that before the alleged measurement was made, a qc measurement was performed and the date was already set to 03-jun-2022.The investigation could not determine the cause for the time and date change.The alleged malfunction was not reproducible.The meter was disassembled for further investigation.A visual inspection was performed of the electronic parts and no abnormalities were found and there was no contamination.The investigation did not identify a product problem.The cause of the event could not be determined.Updated medwatch field: h3 - device evaluation by manufacturer.

• Brand Name: ACCU-CHEK ® INFORM METER
• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14752301
• Report Number: 1823260-2022-01785
• Device Sequence Number: 17592558
• Product Code: NBW
• UDI-Device Identifier: 04015630945757
• UDI-Public: 4015630945757
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K012210
• 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): 08/12/2022

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: 04882458001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2022
• Supplement Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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