BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK INFORM II TEST STRIPS

    MDR report key: 18168758 · Received November 20, 2023

    Report

    Report Number
    1823260-2023-03674
    Event Type
    Malfunction
    Date Received
    November 20, 2023
    Date of Event
    October 25, 2023
    Report Date
    December 21, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    UDI-DI
    00365702428102
    PMA / PMN Number
    K121679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT IS EXPECTED TO BE RETURNED. NO INFORMATION WAS PROVIDED THAT WOULD POINT TO A CAUSE FOR THE DISCREPANCY IN RESULTS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    THE ACCU-CHEK INFORM II STRIPS' EXPIRATION DATE WAS NOT PROVIDED. THE ACCU-CHEK INFORM II METER SERIAL NUMBER WAS (B)(6). THE STRIPS WERE REQUESTED FOR INVESTIGATION. ON A REGULAR BASIS, ACCU-CHEK INFORM STRIPS OF LOTS CURRENTLY VALID IN THE MARKET ARE TESTED AS PART OF ROUTINE RETENTION TESTING AND RESULTS HAVE PASSED THE INTERNAL INSPECTION.

    Description of Event or Problem · 0

    THE REPORTER COMPLAINED OF DISCREPANT GLUCOSE RESULTS FOR 1 PATIENT'S SAMPLE TESTED ON ACCU-CHEK INFORM II METER. INITIAL RESULT: 42 MG/DL (TESTED AT 9:55 AM). 1ST REPEAT RESULT: 93 MG/DL (TESTED AT 9:58 AM). 2ND REPEAT RESULT: 109 MG/DL (TESTED AT 9:59 AM). THE REPORTER CONFIRMED THAT QCS WERE PERFORMED DAILY AND THEY PASSED. THE MEDICAL STAFF BELIEVED THAT EITHER 109 MG/DL OR 93 MG/DL WERE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1599799 ACCU-CHEK INFORM II TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS 670233 00365702428102

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Female CHLORHEXIDINE| EESAZOLIN| SODIUM ACETATE TRIHYDRATE| TYLENOL 650 MG