BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST STEP PREGNANCY TEST (URINE)

    MDR report key: 3042939 · Received March 6, 2013

    Report

    Report Number
    2027969-2013-00190
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 26, 2013
    Report Date
    March 6, 2013
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    JHI
    PMA / PMN Number
    K993203
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONTROL: 25MIU/ML HCG URINE LOT: HCG121226-03, 280.1IU/ML HCG URINE LOT: HCG120926-04, 229.9IU/ML HCG URINE LOT: HCG120903-01, 210.6IU/ML HCG URINE LOT: HCG120910-02. SUMMARY OF RESULTS: THE RETENTION DEVICES MEET QC SPECIFICATION, DETAILS AS BELOW: THE 25MIU/ML HCG URINE CONTROL YIELDED CORRECT POSITIVE RESULTS WITH RETENTION DEVICES AT 3 MINUTES (N=15). THE 280.1IU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTES READING TIME, (N=5). THE 229.9IU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTES READING TIME, (N=5). THE 210.6IU/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. CUSTOMER'S COMPLAINT WA NOT REPLICATED WITH RETAIN DEVICES. RETENTION DEVICES WERE TESTED WITH HCG IN URINE AT CUT OFF AND HIGH LEVELS. ALL RESULTS MET QC SPECIFICATION. NO FALSE NEGATIVES WERE OBTAINED. MFG BATCH RECORD REVIEW DID NOT UNCOVER ANY ABNORMALITIES. ROOT CAUSE COULD NOT BE DETERMINED WITHOUT PATIENT SPECIMEN ANALYSIS IN-HOUSE. TO DATE, 1 COMPLAINT HAS BEEN REPORTED AGAINST THIS LOT. THE HCG FALSE NEGATIVE ISSUE WAS INVESTIGATED UNDER (B)(4). THIS ISSUE WILL BE TRACKED AND TRENDED.

    Description of Event or Problem · 1

    A CUSTOMER ALLEGED RECEIVING A FALSE NEGATIVE RESULT WITH THE FIRST STEP PREGNANCY TEST (URINE.) THE CUSTOMER REPORTED THEY CONFIRMED A POSITIVE RESULT BY BLOOD TEST. NO OTHER PATIENT INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96582 FIRST STEP PREGNANCY TEST (URINE) HCG PREGNANCY TEST JHI ALERE SAN DIEGO, INC FHC-114 07/01/2014

    Patients

    Seq Age Sex Outcome Treatment
    1