BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1701733 · Received May 28, 2010

    Report

    Report Number
    1823260-2010-03230
    Event Type
    Malfunction
    Date Received
    May 28, 2010
    Date of Event
    May 11, 2010
    Report Date
    August 10, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A DEFINITIVE ROOT CAUSE FOR THE ISSUE COULD NOT BE DETERMINED. THE MOST LIKELY CAUSE WAS A SAMPLE PIPETTING FAILURE, POSSIBLY CAUSED BY THE PROBE AND MIXER PADDLE ISSUES FOUND. ANOTHER CAUSE OF A PIPETTING ISSUE COULD ALSO BE NON-VERTICAL PLACEMENT OF THE SAMPLE TUBE IN THE SAMPLING RACK.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED QUESTIONABLE BETA-HCG RESULTS WERE OBTAINED ON 2 PATIENTS: PATIENT A: SAMPLE FROM (B) (6) 2010: HCG = 14,225 RERUN, AFTER RESPINNING SAMPLE: HCG = 221 ************************ PATIENT B: SAMPLE FROM (B) (6) 2010 AT 10:00: HCG = 44 (RESULT RELEASED) THIS SAMPLE WAS NOTED AS "MERKY" BY THE CUSTOMER. RERUN, AFTER RESPINNING SAMPLE: HCG = 17,877 ************************** HCG-STAT REAGENT LOT #: 156661 NO ADVERSE EVENT HAS BEEN ALLEGED REGARDING THESE DISCREPANCIES. AN ENGINEER VISIT FOUND PROBLEMS WITH THE S/R PROBE AND MIXER PADDLE, WHICH WERE REPLACED. THE CUSTOMER BELIEVES THAT THE PROBLEM HAS BEEN RESOLVED.

    Description of Event or Problem · 1

    THERE WERE FOUR ENDEAVOR SPRINT OVER THE WIRE(OTW) DRUG-ELUTING STENTS IMPLANTED, ONE OF THE LEFT MAIN, ONE IN THE MID RCA AND TWO IN THE RIGHT PDA (REFERENCE MFR #'S 2853200-2010-01501, 01502, 01503). AT 30 DAY FOLLOW UP, PATIENT'S CARDIAC STATUS WAS STABLE ANGINA. PATIENT WAS ASYMPTOMATIC / FREE OF SYMPTOMS AT 6 MONTH FOLLOW UP. APPROXIMATELY ONE YEAR POST INDEX PROCEDURE, PATIENT WAS WORKING AND GOT REAL SWEATY AND HAD SHORTNESS OF BREATH AND DEVELOPED CHEST HEAVINESS RADIATING TO SHOULDERS. IT WAS REPORTED THAT THE PATIENT PRESENTED TO LOCAL EMERGENCY ROOM. PATIENT WAS PRESCRIBED NOTIR AND MORPHINE. IT IS REPORTED THAT AN ACUTE NON-STEMI OCCURRED AND A REVASCULARIZATION OF TWO LESIONS WAS CARRIED OUT. AT 12 MONTH FOLLOW UP, PATIENT'S CARDIAC STATUS WAS UNSTABLE ANGINA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECSYS 2010 RACK IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1