BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® HYPERSENSITIVE HTSH

    MDR report key: 3131916 · Received May 29, 2013

    Report

    Report Number
    2122870-2013-00486
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 26, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JLW
    PMA / PMN Number
    K042281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION THE SUSPECT ACCESS HYPERSENSITIVE HTSH REAGENT WAS RETURNED FOR EVALUATION. SERVICE WAS NOT DISPATCHED AS THE CUSTOMER DECLINED AND DID NOT QUESTION INSTRUMENT PERFORMANCE. A DEFINITIVE CAUSE OF THE INCIDENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NON-REPRODUCIBLE THYROID-STIMULATING HORMONE (TSH) RESULT, ABOVE THE NORMAL REFERENCE RANGE, FOR ONE PATIENT, INVOLVING THE ACCESS HYPERSENSITIVE HTSH ASSAY UTILIZED IN CONJUNCTION ACCESS 2 IMMUNOASSAY SYSTEM AND ACCESS HYPERSENSITIVE HTSH CALIBRATOR. THE CUSTOMER QUESTIONED THE RESULT AS THERE WAS NO PATIENT HISTORY AND A HIGHER RESULT WAS OBTAINED AFTER THE SAMPLE WAS REANALYZED ON AN ALTERNATE ACCESS 2 SYSTEM. BOTH THE ORIGINAL AND REPEATED SAMPLES WERE ANALYZED FROM THE PRIMARY TUBE. THE CUSTOMER THEN RE-CENTRIFUGED THE SAMPLE AND REANALYZED THE SAMPLE IN DUPLICATE IN AN INSERT CUP, ON THE ORIGINAL INSTRUMENT. HIGHER TSH RESULTS, ABOVE THE REFERENCE RANGE, WERE OBTAINED. IN ADDITION, THE CUSTOMER ANALYZED THE SAMPLE IN DUPLICATE, ON THE ALTERNATE INSTRUMENT AND HIGHER VALUES, ABOVE THE NORMAL REFERENCE RANGE, WERE ALSO OBTAINED. THE QUESTIONED NON-REPRODUCIBLE RESULT WAS NOT RELEASED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE PATIENT SAMPLE WAS COLLECTED IN A 4 ML BECTON DICKINSON (BD) TUBE WITH GEL. SYSTEM CHECK WAS WITHIN SPECIFICATIONS ON (B)(4) 2013. QUALITY CONTROL (QC) WAS PASSING WITHIN THE CUSTOMER¿S ESTABLISHED LIMITS ON THE DATE OF THE EVENT. THE INSTRUMENT WAS IN NORMAL OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236265 ACCESS® HYPERSENSITIVE HTSH RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW BECKMAN COULTER NA 229509

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR