BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2017-01637

    MDR report key: 6773083 · Received August 8, 2017

    Report

    Report Number
    1823260-2017-01637
    Event Type
    Malfunction
    Date Received
    August 8, 2017
    Date of Event
    July 19, 2017
    Report Date
    August 8, 2017
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE LOW ELECSYS HCG + BETA TEST SYSTEM RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS < 0.100 MIU/ML WITH A DATA FLAG AND WAS REPORTED OUTSIDE THE LABORATORY. THE CLINICIAN DID NOT ACCEPT THE RESULT AND ASKED FOR REPEAT TESTING WITH A NEW SAMPLE. A NEW SAMPLE WAS DRAWN ON (B)(6) 2017 AND THE RESULT WAS 754.0 MIU/ML WITH A DATA FLAG. THE FIRST SAMPLE FROM THE PATIENT WAS THEN REPEATED WITH A NEW REAGENT LOT AND THE RESULT WAS 597.5 MIU/ML WITH A DATA FLAG. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE REAGENT LOT NUMBER WAS 210151. THE EXPIRATION DATE WAS REQUESTED BUT WAS NOT PROVIDED. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. PRECISION TESTING WAS PERFORMED AND WAS ACCEPTABLE. BASED ON THE PROVIDED CALIBRATION, QC, AND ANALYZER DATA, A GENERAL REAGENT OR INSTRUMENT ISSUE WAS NOT SUSPECTED. SEVERAL OF THE PREANALYTIC CONDITIONS AND THE SAMPLE CUP IN USE WERE NOT IN COMPLIANCE WITH THE SPECIFICATIONS. THEREFORE AN ISSUE WITH THE SAMPLE QUALITY WAS LIKELY. ANOTHER TYPICAL CAUSE FOR THIS TYPE OF EVENT WAS INSUFFICIENT MAINTENANCE OF THE ANALYZER.

    Patients

    Seq Age Sex Outcome Treatment
    1