BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 2900492 · Received January 7, 2013

    Report

    Report Number
    1823260-2013-00139
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    December 11, 2012
    Report Date
    January 28, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN COMPACT PLUS SYSTEM 1 (LOT NUMBER 208056, EXPIRATION DATE 09/30/2013). REFERENCE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) FOR THE SUSPECT DEVICE USED IN COMPACT PLUS SYSTEM 2.

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN COMPACT PLUS SYSTEM 1 (LOT NUMBER 208056, EXPIRATION DATE 09/30/2013). (B)(6). DEVICE RECEIVED IN A CONDITION WHICH MADE ANALYSIS IMPOSSIBLE. UNABLE TO TEST BECAUSE AN EMPTY VIAL WAS RETURNED.

    Description of Event or Problem · 1

    CUSTOMER TESTED 0.6 MMOL/L ON COMPACT PLUS SYSTEM 1, AND 9.3 MMOL/L ON COMPACT PLUS SYSTEM 2 WITHIN 10 MINUTES. CUSTOMER TOOK HUMALOG BASED ON THE RESULT OF 9.3 MMOL/L. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7287 ACCU-CHEK ® COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 208056

    Patients

    Seq Age Sex Outcome Treatment
    1 068 YR HUMALOG