BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1893889 · Received November 9, 2010

    Report

    Report Number
    1823260-2010-06656
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 26, 2010
    Report Date
    January 4, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2010 A (B)(4) FACILITY REPORTED A FLO GARD PUMP WHICH INFUSED UNKNOWN MEDICATION PROGRAMMED TO INFUSE IN 24 HOURS WHICH OVERINFUSED IN 2 HOURS INTO A (B)(6) OLD BOY IN THE INTENSIVE CARE UNIT (ICU) FOR AN UNKNOWN DIAGNOSIS. THE CHILD WAS REPORTEDLY IN STABLE CONDITION. IT IS UNKNOWN WHAT MEDICAL INTERVENTION WAS REQUIRED. THE STATUS OF THE PATIENT IS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 214 MG/DL ON AVIVA SYSTEM 1, HAD LOW BLOOD GLUCOSE SYMPTOMS. RETEST WAS 58 MG/DL ON AVIVA SYSTEM 2 WITHIN 10 MINUTES. CALLER WAS ABLE TO RETRIEVE FOOD OR DRINK, SELF TREAT. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. A REQUEST WAS MADE FOR THE RETURN OF THE 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 302855

    Patients

    Seq Age Sex Outcome Treatment
    1 NOVOLOG