BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2022886 · Received March 18, 2011

    Report

    Report Number
    1823260-2011-01491
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 17, 2011
    Report Date
    March 18, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 15 MINUTES: 167 MG/DL, 89 MG/DL, 51 MG/DL, 69 MG/DL, AND 187 MG/DL. CUSTOMER REPORTS THAT HE WAS FEELING HYPOGLYCEMIC SYMPTOMS WITH THE READINGS OF SHAKINESS, SWEATING, LIGHT-HEADEDNESS AND HUNGER. CUSTOMER WAS ABLE TO RETRIEVE AND CONSUME 6 GLUCOSE TABLETS, 12 OZ OF ORANGE JUICE, AND A COOKIE. HE FELT BETTER IN 10-15 MINUTES. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE; HOWEVER, STRIPS HAVE BEEN THROWN AWAY. REPLACEMENT WAS 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 067 YR WELLBUTRIN| DIOVAN| "ROCKSINNOL"| COUMADIN| CPAP| FUROSEMIDE| CYMBALTA| RU 500 INSULIN| AMARYL| PNUEMONIA MEDICATION - TYPE UNKNOWN| LOPURIN| "EIAZAC"| PLAVIX| BETAPACE| "DETIA"| TESTOSTRONE| POTASSIUM CHLORIDE| PROTONIX| PROTOZONE