BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK INFORM II

    MDR report key: 19114871 · Received April 16, 2024

    Report

    Report Number
    1823260-2024-01163
    Event Type
    Malfunction
    Date Received
    April 16, 2024
    Date of Event
    March 16, 2024
    Report Date
    May 21, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K121679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE ACCU-CHEK INFORM II METER IS (B)(6) . THE QC RESULTS ON 18-MAR-2024 AND 20-MAR-2024 FOR LOT NUMBER 670922 WERE ACCEPTABLE. THE CUSTOMER'S TEST STRIPS WERE REQUESTED FOR INVESTIGATION BUT HAVE NOT BEEN RECEIVED AT THIS TIME. IF THE PRODUCT IS RETURNED IN THE FUTURE, A FOLLOW-UP REPORT WILL BE SUBMITTED. 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.

    Additional Manufacturer Narrative · 0

    MEDWATCH FIELDS D9 WERE UPDATED. THE TEST STRIPS WITH LOT NUMBER 670922 WERE RECEIVED FOR INVESTIGATION. THE INVESTIGATION EXAMINED THE VIAL AND DETERMINED THERE WAS NO OBVIOUS DAMAGE OR CONTAMINATION. THE TEST STRIPS WERE TESTED USING GLYCOLYZED BLOOD. THE RESULTS WERE ACCEPTABLE AND NO STRIP DEFECTS WERE OBSERVED. INVESTIGATION RESULTS: STRIP NUMBER-RESULT MG/DL 101 - 119, 104 - 125, 107- 118, 110 - 125, 113 - 121, 116 - 118, 119 - 112, 122 - 119, 125 - 119, 128 - 121, 131 - 121, 134 - 120. THE INVESTIGATION TESTED THE VIAL'S INTEGRITY AND THE RESULTS WERE WITHIN SPECIFICATIONS. THE INVESTIGATION EXAMINED THE PRIMARY PACKAGING SEAL AND DETERMINED THE RETURNED PRODUCT WAS APPROPRIATELY SEALED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION OF QUESTIONABLE GLUCOSE RESULTS FOR FOUR PATIENTS TESTED WITH THE ACCU-CHEK INFORM II METER WHEN CONSECUTIVE METER TESTINGS WERE PERFORMED. ON OR ABOUT (B)(6) 2024: PATIENT 1 THE FIRST METER RESULT WAS 400 MG/DL. THE SECOND METER RESULT WAS 180 MG/DL.  PATIENT 2 THE FIRST METER RESULT WAS 400 MG/DL. THE SECOND METER RESULT WAS 180 MG/DL. THE RESULTS WERE WITHIN 10 MINUTES OF EACH OTHER. ON (B)(6) 2024: PATIENT 3 THE METER RESULT AT 12:14 AM WAS 440 MG/DL. THE METER RESULT AT 12:16 AM WAS 116 MG/DL.  PATIENT 4 THE METER RESULT AT 11:59 AM WAS 400 MG/DL. THE METER RESULT AT 12:09 PM WAS 141 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672350 ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS ASKU, 670922

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown