BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITEST HCG PREGNANCY TEST

    MDR report key: 4148846 · Received October 7, 2014

    Report

    Report Number
    1217157-2014-00149
    Event Type
    Malfunction
    Date Received
    October 7, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JHI
    PMA / PMN Number
    K032563
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE RETURNED PATIENT SAMPLE, SIEMENS TECHNICAL OPERATION TEAM INDICATED THAT RETURNED PATIENT URINE SAMPLE WAS APPEARED DARK AND BLOODY, WITH MUCOUS, HIGHLY VISCOUS AND CLOUDY AFTER ALLOWING THAWING AT ROOM TEMPERATURE. MOREOVER, PATIENT URINE ALSO CONTAINED HEAVY SOLID SEDIMENTS AND HAD A STRONG ODOR. SIEMENS TECHNICAL OPERATION TEAM TESTED EIGHTEEN (18) REPLICATES USING CUSTOMER RETURNED PATIENT URINE AND CUSTOMER RETURNED CASSETTES. MOREOVER THEY ALSO TESTED ADDITIONAL 6 REPLICATES USING POOLED CLEAR NON PREGNANT MALE URINE AND RETURNED CUSTOMER CASSETTE HCG LOT #040038. SIEMENS TECHNICAL OPERATION TEAM INDICATED THAT DURING CUSTOMER RETURNED URINE AND CASSETTE TESTING, FLOW ISSUES AND REAGENT MEMBRANE BLOCKAGES WERE OBSERVED DUE TO HIGH VISCOSITY OF URINE. UV LIGHT ANALYSIS OF CASSETTES WITH FLOW ISSUES SHOWED URINE FLOW WAS GREATLY IMPACTED AT THE SAMPLE ABSORBENT PAD AREA. BOTH NEGATIVE AND POSITIVE RESULTS WERE OBTAINED FROM TESTING LOT #040038 WITH PATIENT URINE SAMPLE. WHEREAS, TESTING PERFORMED USING SAME CUSTOMER RETURNED CASSETTES WITH NON-PREGNANT MALE URINE GAVE ACCURATE NEGATIVE RESULTS. FURTHERMORE, RESULTS FROM SERUM TESTING SHOWED PATIENT URINE CONTAINED 1,468,264.00 MIU/ML OF HCG. 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 (B)(6) MONTHS PREGNANT. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626825 CLINITEST HCG PREGNANCY TEST CLINITEST HCG PREGNANCY TEST JHI SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1