BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2015-03576

    MDR report key: 4812844 · Received June 2, 2015

    Report

    Report Number
    1823260-2015-03576
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Date of Event
    May 16, 2015
    Report Date
    June 2, 2015
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE TROPONIN THS RESULTS FOR TWO SAMPLES FROM ONE PATIENT AND ONE SAMPLE FROM ANOTHER PATIENT. FOR PATIENT A: A TOTAL OF FOUR SAMPLES WERE DRAWN FROM THE PATIENT. THE DOCTOR QUESTIONED THE RESULT OF 36.64 (37) NG/L FOR SAMPLE 3 AND THE RESULT OF 3.90 (<5) NG/L FOR SAMPLE 4. REPEAT TESTING WAS THEN PERFORMED ON THESE TWO SAMPLES. FOR PATIENT B: A TOTAL OF FOUR SAMPLES WERE DRAWN FROM THE PATIENT. THE LABORATORY QUESTIONED THE RESULT OF 53.75 (54) NG/L FOR SAMPLE 2 AND REPEATED TESTING. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE REAGENT LOT NUMBER WAS 182603 WITH AN EXPIRATION DATE OF 04/29/2016. DURING INVESTIGATION AT THE SITE, PRECISION TESTING WAS ACCEPTABLE. NO RELEVANT HARDWARE ALARMS WERE FOUND EXCEPT ABNORMAL SAMPLE ASPIRATION ALARMS ON THE INITIAL TESTING OF SAMPLE 3 FOR PATIENT A. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. BASED ON THE PROVIDED INFORMATION, AN ISSUE WITH THE INSTRUMENT OR WITH THE CALIBRATION/REAGENT WAS UNLIKELY. A PRE-ANALYTICAL ISSUE WITH THE SAMPLES WAS MOST LIKELY THE CAUSE BASED ON THE ANALYZER ALARMS.

    Patients

    Seq Age Sex Outcome Treatment
    1