BEUDAMED
    FDA Adverse Event Summary report: N

    CLINITEK STATUS+

    MDR report key: 4139314 · Received October 3, 2014

    Report

    Report Number
    1217157-2014-00144
    Date Received
    October 3, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 5, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JIL
    PMA / PMN Number
    K091216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER INDICATED THAT PATIENT SAMPLE WAS RAN ON 3 DIFFERENT SERIAL NUMBERS: (B)(4), (B)(4) AND (B)(4). CUSTOMER PROVIDED A SPREADSHEET OF HCG RESULTS. IT WAS UNCLEAR FROM THE SPREADSHEET WHETHER THIS WAS THE SAME PATIENT OR MULTIPLE PATIENTS' RESULTS. BASED ON THE RESULTS FROM SERUM TESTING, PATIENT URINE A CONTAINED 824,496.00 MIU/ML OF HCG, PATIENT URINE B CONTAINED 827,873MIU/ML, AND PATIENT URINE C CONTAINED 1,344,828MIU/ML. MOREOVER TESTING WITH CUSTOMER RETURNED CASSETTE LOTS #040038/041371 WITH POOLED NON PREGNANT MALE URINE GAVE AN EXPECTED NEGATIVE RESULT WHICH INDICATES CUSTOMER RETURNED CASSETTES PERFORMED AS EXPECTED WITH NORMAL CLEAR NON PREGNANT MALE URINE SAMPLES. AS PER CLINITEST HCG PREGNANCY TEST IFU, "HIGH-DOSE HOOK EFFECT - HIGH-DOSE HOOK EFFECTS ARE NOT SEEN WITH THIS PRODUCT UNTIL THE URINE HCG LEVEL EXCEEDS 600,000 MIU/ML, A LEVEL TWO TO THREE TIMES HIGHER THAN THE HIGHEST LEVEL SEEN FOR PREGNANT INDIVIDUALS."

    Description of Event or Problem · 1

    CUSTOMER REPORTED FALSE NEGATIVE HUMAN CHORIONIC GONADOTROPIN (HCG) RESULT ON THE INSTRUMENT. CUSTOMER ALSO REPORTED THAT PATIENT WAS 7 WEEK PREGNANT. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617967 CLINITEK STATUS+ CT STATUS+ JIL SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1