BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSULT DIAGNOSTICS HCG CASSETTE

    MDR report key: 3182573 · Received June 14, 2013

    Report

    Report Number
    2027969-2013-00481
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 14, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    PMA / PMN Number
    K062361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER DID NOT PROVIDE A LOT NUMBER. NO SAMPLE IS RETURNING. UNABLE TO PERFORM FURTHER INVESTIGATION TO DETERMINE ROOT CAUSE. RESULTS SHOULD NOT BE READ AFTER 10 MINUTES PER PRODUCT INSERT. IF HCG LEVELS ARE LOW OR NEAR CUT OFF, A NEGATIVE RESULT COULD INITIALLY APPEAR AND TEST LINE WOULD DARKEN OVER TIME. THIS ISSUE WILL BE TRACKED AND TRENDED. NO CORRECTIVE ACTION AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED OBSERVING A FALSE NEGATIVE RESULT USING THE CONSULT DIAGNOSTICS HCG URINE CASSETTE. CUSTOMER CALLED TO VERIFY READ TIME OF THE CONSULT DIAGNOSTICS HCG URINE CASSETTE RAPID TEST BECAUSE ONE PT RESULTED NEGATIVE AT 5 MINUTES, THEN NOTICED AT 10 MINUTES TEST WAS POSITIVE. CUSTOMER STATED THE CONFIRMATION CAME BACK POSITIVE. CUSTOMER DID NOT PROVIDE FURTHER INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272392 CONSULT DIAGNOSTICS HCG CASSETTE HCG PREGNANCY JHI ALERE SAN DIEGO, INC. FHC-A102-OBC554

    Patients

    Seq Age Sex Outcome Treatment
    1