BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK MOBILE TEST STRIPS

    MDR report key: 1933825 · Received December 21, 2010

    Report

    Report Number
    1823260-2010-07576
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    December 9, 2010
    Report Date
    January 18, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (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

    CALLER REPORTED (B)(6) CUSTOMER HAD AN ACCU-CHEK MOBILE RESULT OF 530 MG/DL AT 9:20 PM, WAS GIVEN 15 UNITS OF NOVORAPID INSULIN. A 10:30 PM RESULT WAS 157 MG/DL, 10:35 PM RESULT WAS 56 MG/DL, THE CUSTOMER'S SYMPTOMS WERE DESCRIBED AS, "UNCONSCIOUSNESS, UNRESPONSIVE, SEIZURE". THE CUSTOMER WAS GIVEN A "GLUKAGON" INJECTION. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 277059

    Patients

    Seq Age Sex Outcome Treatment
    1 010 YR NOVORAPID