BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM-E PSA (FOR USE WITH PHOTON ERA)

    MDR report key: 46220 · Received October 23, 1996

    Report

    Report Number
    2022635-1996-00006
    Event Type
    Malfunction
    Date Received
    October 23, 1996
    Report Date
    October 23, 1996
    Manufacturer
    HYBRITECH INC.
    Product Code
    LTJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    AN ELDERLY MALE PT HAS BEEN TESTED MANY TIMES OVER THE PAST YEAR (EXACT DATES UNAVAILABLE) USING THE ASSAY. IN THE SPRING, THE PT'S PSA RESULT WAS 35 NG/ML AND IN AUGUST, THE PT'S PSA RESULT WAS 65 NG/ML. THE PHYSICIAN DID NOT BELIEVE THE 65 NG/ML RESULT AND SENT A SAMPLE TO ANOTHER CLINIC FOR TESTING. THE PSA RESULT WAS 1.8 NG/ML. THE PT HAD A BIOPSY PERFORMED SOME TIME AGO BUT THE REPORTING INDIVIDUAL DID NOT BELIEVE IT WAS AS A RESULT OF THE PSA RESULTS. THE PT WAS SUBSEQUENTLY DIAGNOSED WITH CHRONIC PROSTATITIS. NO TESTING WAS PERFORMED AS THE KIT LOT NUMBER WAS NOT KNOWN, AND NO SAMPLE WAS RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TANDEM-E PSA (FOR USE WITH PHOTON ERA) PROSTATE-SPECIFIC ANTIGEN TEST LTJ HYBRITECH INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *