BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUELINE PREGNANCY TEST

    MDR report key: 1211323 · Received October 22, 2008

    Report

    Report Number
    3005689981-2008-00045
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    September 4, 2008
    Report Date
    October 22, 2008
    Manufacturer
    INNOVACON, INC.
    Product Code
    LCX
    PMA / PMN Number
    K993483
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RETENTION DEVICE TESTING. SUMMARY OF RESULTS: THE RETENTION OF DEVICES MEET QC SPECIFICATION. CORRECT POSITIVE RESULTS WERE OBSERVED WHEN TESTED WITH 25MIU/ML HCG URINE CONTROL AT 3 MINUTES READ TIME. THE 100 MIU/ML AND 206.0IU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTES READING TIME. THE CLINICAL URINE SPECIMENS WERE TESTED WITH RETENTION DEVICES, AND ALL YIELDED CORRECT NEGATIVE RESULTS. ALL THE C LINES APPEARED WITHIN 90 SECONDS, AND THE C LINE INTENSITY > G9 AT 3 MINUTES READING TIME. PROBABLE ROOT CAUSE: FN ISSUE: IN GENERAL THE HCG LEVELS WILL DOUBLE EVERY 48-72 HOURS, AND IT IS KNOWN THAT URINE SAMPLE WILL BE INFLUENCED BY MANY FACTORS. IF THE PT DRINKS TOO MUCH WATER WHICH WILL DILUTE THE URINE BEFORE THE TEST, AND A FALSE NEGATIVE RESULT MAY OCCUR WHEN THE LEVELS OF HCG ARE BELOW SENSITIVITY LEVEL OF THE TEST. DIFFERENT RAPID TEST MAY HAVE DIFFERENT SENSITIVITY. IF PREGNANCY IS STILL SUSPECTED, A FIRST MORNING URINE SPECIMEN SHOULD BE COLLECTED 48HRS LATER AND TESTED. NO LINE ISSUE: THE "FLOODING" PROBLEM MAY OCCUR IF CUSTOMERS DIP THE STRIP TO URINE SAMPLE TOO DEEPLY AND EXCEED THE MAX LINE. IN THAT CASE, THERE WILL BE NO C/T LINE OR TAKE A LONGER TIME TO GET THE C/T LINE. THE "NO RUN" PROBLEM MAY OCCUR BECAUSE OF INSUFFICIENT URINE SAMPLE. CONCLUSION: THE RETENTION DEVICES MEET QC SPECIFICATION. NO FALSE NEGATIVE RESULT AND NO LINE RESULT WAS OBSERVED. SO THIS COMPLAINT IS NOT CONFIRMED.

    Description of Event or Problem · 1

    PT HAD PERIOD THAT WAS 1 MONTH OVERDUE AND TOOK TEST TWICE WITH NEGATIVE RESULTS. WENT TO PHARMACIST THAT PERFORMED TEST AND ALSO GOT NEGATIVE RESULT. SHE STILL THOUGHT SHE WAS PREGNANT AND WENT TO DOCTOR'S OFFICE, WHERE THE RESULT WAS POSITIVE. CUSTOMER WAS TOLD THAT DIFFERENCE MAY BE DUE TO TIMING OF TEST. DOCTOR VISIT MAY HAVE BEEN LATER AND HAD TIME TO INCREASE HCG LEVELS. ALSO, TEST AT DOCTOR'S OFFICE MAY HAVE HIGHER SENSITIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUELINE PREGNANCY TEST HCG PREGNANCY TEST LCX INNOVACON, INC. FHC-101H HCG7110037

    Patients

    Seq Age Sex Outcome Treatment
    1