BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUPID HCG URINE PREGNANCY CASSETTE

    MDR report key: 2821996 · Received October 1, 2012

    Report

    Report Number
    2027969-2012-01425
    Event Type
    Malfunction
    Date Received
    October 1, 2012
    Date of Event
    September 17, 2012
    Report Date
    October 1, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    PMA / PMN Number
    K993317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER: HCG1090058. EXPIRATION DATE: 09/01/2013. CONTROL LOT: 20MIU/ML HCG URINE LOT: HCG120130-01, 229.9IU/ML URINE LOT: HCG120903-01, 210.0IU/ML HCG URINE LOT: HCG120517-01, 202IU/ML HCG URINE LOT: HCG120522-01; CLINICAL POSITIVE URINE FORM 6 PREGNANCY WOMEN. SUMMARY OF RESULTS: THE RETENTION DEVICES MEET QC SPECIFICATION, DETAILS AS BELOW: CORRECT POSITIVE RESULTS WERE OBSERVED WHEN TESTED WITH 20MIU/ML HCG URINE CONTROL AT 3 MINUTE READ TIME. (N=15); THE 210.0IU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTE READ TIME. (N=3); THE 229.9IU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTE READ TIME. (N=3); THE 202IU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTE READ TIME. (N=3); . CORRECT POSITIVE RESULTS WERE OBSERVED WHEN TESTED WITH 6 CLINICAL URINE SAMPLES AT 3 MINUTES READ TIME. (N=1 FOR EACH SAMPLE). CONCLUSION: FROM RETAIN TESTING WITH IN-HOUSE CONTROL, THE CLIENT'S RESULT WAS NOT REPLICATED AND THE PRODUCT PERFORMED AS EXPECTED MEETING QC SPECIFICATIONS. VERIFIED THE PRODUCT NUMBER, PRODUCT DESCRIPTION, LOT NUMBER AND BATCH RECORD; NO ABNORMAL RESULTS WERE FOUND. INVESTIGATION ON RETURNED PRODUCT IS PENDING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED POTENTIAL FALSE NEGATIVE URINE HCG RESULTS WITH QUPID HCG URINE PREGNANCY CASSETTE. NO OTHER INFORMATION WAS PROVIDED; NO PATIENT INFORMATION; NO CONFIRMATION TESTING METHOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUPID HCG URINE PREGNANCY CASSETTE HCG PREGNANCY TEST JHI ALERE SAN DIEGO, INC. FHC-102-ONC44 HCG1090058

    Patients

    Seq Age Sex Outcome Treatment
    1