BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK® AVIVA TEST STRIPS

    MDR report key: 2001937 · Received February 27, 2011

    Report

    Report Number
    1823260-2011-01056
    Event Type
    Malfunction
    Date Received
    February 27, 2011
    Date of Event
    February 8, 2011
    Report Date
    April 14, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CALLER REPORTED WIFE HAD AVIVA RESULT OF 16 MG/DL AT 12:13 PM, WIFE WAS HAVING CONVULSIONS. HUSBAND TREATED WIFE BY SPRINKLING SUGAR IN HER MOUTH AND USING A STRAW TO DROP GRAPE JUICE INTO HER MOUTH. 12:23 PM RESULT WAS 56 MG/DL, 12:33 PM RESULT WAS 61 MG/DL. EMS ARRIVED AT 12:38 PM AND RESULT WAS "BELOW 20" MG/DL. CUSTOMER WAS TREATED WITH GLUCOSE DRIP AND SHE BEGAN TO COME AROUND. CUSTOMER WAS TAKEN TO THE HOSPITAL TO BE MONITORED, WAS NOT ADMITTED. CUSTOMER WAS RELEASED 2 HOURS LATER WITH A READING OF 141 MG/DL. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. 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® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 302641

    Patients

    Seq Age Sex Outcome Treatment
    1 061 YR REINAGEL| SENSIPAR| NOVOLOG 70/30| ROPINIROLE 3XDAY