BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK INFORM II TEST STRIPS

    MDR report key: 19613797 · Received June 26, 2024

    Report

    Report Number
    1823260-2024-01860
    Event Type
    Malfunction
    Date Received
    June 26, 2024
    Date of Event
    June 1, 2024
    Report Date
    July 18, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    UDI-DI
    00365702428102
    PMA / PMN Number
    K121679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE TEST STRIPS WERE FURTHER TESTED USING GLYCOLYZED BLOOD, AND ALL RESULTS WERE ACCEPTABLE. INVESTIGATION RESULTS IN MG/DL: 115, 122, 112, 114, 113, 112, 107, 116 109, AND 109. REFERENCE LOT AVERAGE IN MG/DL: 112.19. THE INVESTIGATION INSPECTED THE RETURNED VIAL AND OBSERVED NO OBVIOUS SIGNS OF DAMAGE OR CONTAMINATION. THE VIAL'S INTEGRITY WAS TESTED AND THE RESULT WAS ACCEPTABLE. THE INVESTIGATION DETERMINED THAT THE PRIMARY PACKAGING SEAL WAS ACCEPTABLE FOR THE RETURNED VIAL AND THERE IS EVIDENCE TO SUPPORT THAT THE RETURNED PRODUCT WAS APPROPRIATELY SEALED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE CUSTOMER'S ACCU-CHEK INFORM II METER IS (B)(6). THE METER AND TEST STRIPS WERE RECEIVED FOR INVESTIGATION AND WERE TESTED USING RETENTION CONTROLS. INVESTIGATION RESULTS: CONTROL RANGES: LEVEL 1: 30-60 MG/DL, LEVEL 2: 261-353 MG/DL RESULTS FROM CUSTOMER'S METER AND TEST STRIPS: LEVEL 1: 44, 45, 44 MG/DL LEVEL 2: 300, 299, 298 MG/DL ALL RETURNED RESULTS ARE WITHIN ACCEPTABLE RANGE. 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. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED A QUESTIONABLE GLUCOSE RESULT FOR ONE PATIENT TESTED WITH THE ACCU-CHEK INFORM II METER WHEN COMPARED WITH THE LABORATORY RESULT. THE METER RESULT AT 12:18 AM WAS 67 MG/DL. THE METER RESULT AT 2:24 AM WAS REPORTEDLY A DATA FLAG INDICATING A RESULT BELOW 50 MG/DL. THE METER RESULT AT 2:49 AM WAS 76 MG/DL. THE LABORATORY RESULT AT 2:59 AM WAS 55 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689107 ACCU-CHEK INFORM II TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS 670943 00365702428102

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Male