BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® INFORM METER

    MDR report key: 7276212 · Received February 16, 2018

    Report

    Report Number
    1823260-2018-00468
    Event Type
    Malfunction
    Date Received
    February 16, 2018
    Date of Event
    January 29, 2018
    Report Date
    March 20, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K012210
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED THEREFORE AN ADDITIONAL INVESTIGATION WAS NOT POSSIBLE. THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE GLUCOSE RESULT FROM TWO ACCU-CHEK INFORM II METERS FOR ONE PATIENT. FOR BOTH METERS, THE NURSES CLAIMED THEY PERFORMED ONE MEASUREMENT FOR THE PATIENT BUT IN THE COBAS IT 1000 DMS THERE ARE TWO RESULTS. THE NURSES CLAIMED THE RESULT THEY RECEIVED ON EACH METER WAS A NUMERICAL GLUCOSE RESULT AND NOT AN "LO" RESULT. THE POINT OF CARE COORDINATOR OBSERVED AN "LO" RESULT AND A NUMERICAL RESULT FOR THE SAME TIMEFRAME ON THE COBAS IT 1000 DMS AND IN THE METER MEMORY FOR EACH METER. OF THE DATA PROVIDED, THERE WAS AN ERRONEOUS RESULT ON EACH METER. THE CUSTOMER¿S POLICY REQUIRES LABORATORY TESTING IF THE METER RESULT IS "LO", HOWEVER, THERE WAS NO SAMPLE COLLECTED FOR LABORATORY TESTING. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT AND NO TREATMENT WAS GIVEN TO THE PATIENT BASED ON THE RESULTS. THE ACCU-CHEK INFORM II STRIP LOT 476124 WAS USED WITH BOTH METERS. THE EXPIRATION DATE WAS NOT PROVIDED. THE QC WAS ACCEPTABLE PRIOR TO THE EVENT. ROUTINE RETENTION TESTING IS PERFORMED. RETENTION TESTING DATA IS REVIEWED AND APPROPRIATE ACTIONS ARE TAKEN AS NEEDED. REFER TO THE MEDWATCH (B)(6) FOR THE TWO METERS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121160 ACCU-CHEK ® INFORM METER BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1