BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURE-VUE URINE HCG

    MDR report key: 2063063 · Received April 11, 2011

    Report

    Report Number
    2027969-2011-00766
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Date of Event
    March 19, 2011
    Report Date
    April 11, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    PMA / PMN Number
    K993317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER(S): HCG0060079. EXPIRATION DATE(S): 04/2012. CONTROL: 25MIU/ML HCG URINE CONTROL LOT: HCG110105-01; 100MIU/ML HCG URINE CONTROL LOT: HCG100513-01; 278.9IU/ML HCG URINE CONTROL LOT: HCG110124-01. THE RETENTION DEVICES MEET QC SPECIFICATIONS. CORRECT POSITIVE RESULTS WERE OBSERVED WHEN TESTED WITH 25MIU/ML HCG URINE CONTROL AT 3 MINUTES READING TIME. (N=5). THE 100MIU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTES READING TIME. (N=5). THE 278.9IU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTES READING TIME. (N=4). CONCLUSION: FROM RETAIN TESTING WITH IN-HOUSE CONTROL, THE CLIENT'S RESULT WAS NOT REPLICATED, AND THE PRODUCT PERFORMED AS EXPECTED. THE RETURN DEVICES MEET QC SPECIFICATIONS. CORRECT POSITIVE RESULTS WERE OBSERVED WHEN TESTED WITH 25MIU/ML HCG URINE CONTROL AT 3 MINUTES READING TIME. (N=5). THE 100MIU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTES READING TIME. (N=5). THE 278.9 IU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTES READING TIME. (N=5). CONCLUSION: FROM RETURN TESTING WITH IN-HOUSE CONTROL, THE CLIENT'S RESULT WAS NOT REPLICATED, AND THE PRODUCT PERFORMED AS EXPECTED. CORRECTIVE ACTION NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER REPORTED POTENTIAL FALSE NEGATIVE HCG RESULTS. RESULTS AS FOLLOWS: PATIENT CAME INTO THE EMERGENCY DEPARTMENT FOR FLANK PAINS. LAST MENSTRUAL PERIOD: (B)(6) 2011. URINE SPECIMEN COLLECTED VIA CLEAN CATCH MIDSTREAM. URINE SPECIMEN NOT AVAILABLE FOR FURTHER TESTING; WAS THROWN AWAY. CT SCAN OF ABDOMEN REVEALED A RESEMBLANCE OF FETUS AND BETA QUANTITATIVE WAS 22,932 ML/IU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURE-VUE URINE HCG HCG PREGNANCY TEST JHI ALERE SAN DIEGO, INC. FHC-102-OBC513 HCG0060079

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR