BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1715520 · Received June 10, 2010

    Report

    Report Number
    1823260-2010-03478
    Event Type
    Malfunction
    Date Received
    June 10, 2010
    Date of Event
    May 24, 2010
    Report Date
    July 22, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B) (6). CALLER DID NOT KNOW WHICH AVIVA SYSTEM PRODUCED THE ERRONEOUS RESULTS. THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN AVIVA SYSTEM (LOT NUMBER 202431, EXPIRATION DATE 06/30/2011). (B) (4). (B) (4)

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). CALLER DID NOT KNOW WHICH AVIVA SYSTEM PRODUCED THE ERRONEOUS RESULTS. THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN AVIVA SYSTEM (LOT NUMBER 202431, EXPIRATION DATE 06/30/2011). (B)(4). CORRECTED THE LOT NUMBER TO 202427

    Description of Event or Problem · 1

    THE FACILITY REPORTED TO BAXTER THAT THE RESERVOIR OF AN INTERMATE LV 250 DEVICE RUPTURED NEAR THE END OF AN INFUSION ON AN (B)(6) MALE PATIENT. THE DEVICE WAS INFUSING 1 GRAM OF VANCOMYCIN IN A 250ML DILUENT SOLUTION WHEN THE RUPTURE OCCURRED. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    CALLER STATES NEONATE PATIENT TESTED 40 MG/DL, 41 MG/DL, AND 42 MG/DL ON THE AVIVA SYSTEM. THE SAME NEONATE TESTED 80 MG/DL ON THE SENSOR SYSTEM. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE, AND 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 202427

    Patients

    Seq Age Sex Outcome Treatment
    1