BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDI-LAB PERFORMANCE HCG URINE TEST-CASSETTE

    MDR report key: 2370137 · Received November 11, 2011

    Report

    Report Number
    2027969-2011-02328
    Event Type
    Malfunction
    Date Received
    November 11, 2011
    Date of Event
    April 19, 2011
    Report Date
    November 11, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    PMA / PMN Number
    K993317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER(S): HCG0090161, EXPIRATION DATE(S): 08/2012. CONTROL: 25MIU/ML HCG URINE CONTROL LOT: HCG110328-01, 100MIU/ML HCG URINE CONTROL LOT: HCG110307-01, 241.0IU/ML HCG URINE CONTROL LOT: HCG111020-01. SUMMARY OF RESULTS: THE RETENTION DEVICES MEET QC SPECIFICATION. DETAILS AS BELOW: CORRECT POSITIVE RESULTS WERE OBSERVED WHEN TESTED WITH 25MIU/ML HCG URINE CONTROL AT 3 MINS READING TIME. (N=5). THE 100MIU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINS READING TIME. (N=5). THE 241.0IU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINS READING TIME. (N=5). FROM RETAIN TESTING WITH IN-HOUSE CONTROL, THE CLIENT'S RESULT WAS NOT REPLICATED, AND THE PRODUCT PERFORMED AS EXPECTED. NO PRODUCT OR SAMPLES WERE RETURNED. CORRECTIVE ACTION NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER ALLEGED FALSE NEGATIVE HCG RESULTS. RESULTS AS FOLLOWS: LOT HCG0090161, EXPIRATION 08/2012. NO REPORT OF DEATH OR SERIOUS INJURY. NO OTHER COMPLAINT DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDI-LAB PERFORMANCE HCG URINE TEST-CASSETTE HCG PREGNANCY JHI ALERE SAN DIEGO, INC. FHC-102-OBW12 HCG0090161

    Patients

    Seq Age Sex Outcome Treatment
    1