BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 1812996 · Received August 24, 2010

    Report

    Report Number
    1823260-2010-05036
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    August 17, 2010
    Report Date
    September 24, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PREMATURE INFANT DELIEVERED VIA CESAERIAN SECTION, TRANSFERRED TO NICU. DURING NURSE'S ASESSMENT IN NICU, FOUND BLUE LUER-LOCK TO IV TUBING TO BE LEAKING ONTO INFANT'S BED. BLUE LUER-LOCK AND EXTENSION TUBING CHANGED TO PICC LINE. THE LEAK WAS NOT AT THE CONNECTION SITE, AND APPEARED TO BE LEAKING FROM THE HARD DARK BLUE PLASTIC AREA. PLEASE NOTE: WE HAVE HAD 2 OTHER INSTANCES WITH THE SAME BLUE LUER-LOCK ALSO FOUND TO BE LEAKING. HOWEVER, THESE OTHER INSTANCES OCCURRED ON OUR ONCOLOGY UNIT DURING CHEMO ADMINISTRATION.====================== HEALTH PROFESSIONAL'S IMPRESSION======================DEFECTIVE DEVICE.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE COMPACT PLUS SYSTEM WITHIN 10 MINUTES: 248 MG/DL AND 124 MG/DL. 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 ® COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 20716041

    Patients

    Seq Age Sex Outcome Treatment
    1 056 YR LISINOPRIL| ZETIA| ATENOLOL| SIMVASTATIN| ASPIRIN| LANTUS| HUMULOG