BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1980224 · Received February 7, 2011

    Report

    Report Number
    1823260-2011-00649
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    January 31, 2011
    Report Date
    February 10, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    REPORTER ALLEGED THE CUSTOMER OBTAINED THE RESULTS OF HI (GREATER THAN MG/DL) AND 201 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE AVIVA SYSTEM. NO 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 302869

    Patients

    Seq Age Sex Outcome Treatment
    1 084 YR CRESTOR ROSUVASTATIN CA| LISINOPRIL| ACARBOSE| STENT| CINNAMON| NOVOLOG| NPH| ARTIFICIAL EYES| CLARITIN| HYDROCHLOROTHIAZIDE TRIAMTERENE| HEARING AIDS| APNEA MONITOR| OMEPRAZOLE| FISH OIL| MELATONIN| CARVEDILOL| FINASTERIDE| BAYER| GARLIC| DIGOXIN| SERTRALINE HYDROCHLORIDE