BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1832466 · Received September 13, 2010

    Report

    Report Number
    1823260-2010-05392
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    September 6, 2010
    Report Date
    September 13, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE CUSTOMER OBTAINED THE RESULTS OF 38 MG/DL, 52 MG/DL, 62 MG/DL AND 69 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE AVIVA SYSTEM. REPORTER STATED THAT SHE GAVE THE CUSTOMER HIS MEDICATIONS AND A MEAL RIGHT AFTER THESE READINGS WERE OBTAINED. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    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 302627

    Patients

    Seq Age Sex Outcome Treatment
    1 015 YR INSTANT GLUCOSE (AS NEEDED)| IV LIKE DEVICE| CORNSTARCH (EVERY 3 HOURS)| PROTEIN PILLS| FISH OIL| IRON| DEXTROSE VIA ABDOMINAL PORT (AS NEEDED)| VITAMINS| "TOLEREX" (NIGHTLY)