BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1874223 · Received October 19, 2010

    Report

    Report Number
    1823260-2010-06205
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 27, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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

    THE FACILITY REPRESENTATIVE CONTACTED BAXTER TO REPORT AN I-PUMP IN WHICH, WHILE A NURSE CHANGED THE EPIDURAL BAG, IT WAS NOTICED THAT THE ALARM DID NOT SOUND ON OPENING THE DOOR OF THE DEVICE. THE DEVICE WOULD NOT ALLOW THE NURSE TO CHANGE THE VOLUME WHEN THE NEW BAG WAS ERECTED. THERE WAS NO ADVERSE EVENT, PATIENT INJURY, OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING THE RESULTS OF 562 MG/DL, 342 MG/DL AND 93 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE AVIVA SYSTEM. REPORTER STATED THAT ABOUT 1.5 HOURS PRIOR, HE HAD TAKEN 15 UNITS OF THE APIDRA THAT HE NORMALLY TAKES AT HIS DINNER MEAL. 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 302646

    Patients

    Seq Age Sex Outcome Treatment
    1 054 YR