BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT TESTPACK RSV

    MDR report key: 135238 · Received November 26, 1997

    Report

    Report Number
    1451914-1997-00034
    Event Type
    Other
    Date Received
    November 26, 1997
    Date of Event
    October 30, 1997
    Report Date
    November 25, 1997
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GQG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PURPOSE OF THE INVESTIGATION WAS TO INVESTIGATE THE COMPLAINT FOR DISCREPANT RESULTS OF NEGATIVE TESTPACK RSV VS POSITIVE KALLESTAD RSV. USING THE RETURNED KIT MATERIAL, TWO REPLICATES OF PANEL 0 (PHOSPHATE BUFFERED SALINE) AND TWO REPLICATES OF PANEL 1 (VEAL INFUSION BROTH), EACH KNOWN NEGATIVES, AND TWO REPLICATES OF PANEL 2 (LOW ANTIGEN LEVEL RSV PANEL MEMBER) AND ONE REPLICATE OF THE RETURNED TESTPACK RSV POSITIVE CONTROL, WERE TESTED. IN SUMMARY, RETURNED MATERIAL PERFORMED APPROX AND MET ALL PERFORMANCE CRITERIA. KNOWN NEGATIVE SAMPLES YIELDED NEGATIVE RESULTS WHICH WERE CLEAR AND EASY TO INTERPRET. KNOWN POSITIVES READ AT THE APPROPRIATE LEVELS WITH BAR INTENSITIES ACCEPTABLE PER REFERENCE PHOTOS (SERIES 002). THESE MASTERLOTS PERFORMED ACCORDING TO PACKAGE INSERT (83-4292/R2) CLAIMS. A FALSE POSITIVE RESULT ON THE KALLESTAD KIT CANNOT BE RULED OUT. THE KALLESTAD RSV IS NOT A CONFIRMATORY ASSAY FOR ABBOTT TESTPACK RSV. DISCREPANT RESULTS MAY BE DUE TO SAMPLE HANDLING, CONFIRMATORY METHODOLOGY, ASSAY TECHNIQUE AND/OR ANY ASSAY'S INHERENT LIMITATIONS. THE COMPLAINT IS NOT CONFIRMED. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    ON 10/30/97 A NEGATIVE RESULT FOR THE TESTPACK RSV ASSAY WAS REPORTED FOR A PT SAMPLE. THE SAME PT SAMPLE LATER TESTED POSITIVE WITH AN EIA ASSAY. A NASAL WASHING SAMPLE WAS COLLECTED WITH A SALINE TRANSPORT MEDIUM. THE TESTPACK PROTOCOL WAS FOLLOWED, HOWEVER THE SALINE TRANSPORT MEDIA WAS NOT USED AS A NEGATIVE CONTROL. ACCORDING TO THE ACCOUNT, THE SAMPLE WAS STORED FOR A FEW HRS 2-8C UNTIL TESTED AND RUN ONE TIME WITH THE TESTPACK. NO FURTHER PT INFO AVAILABLE. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT TESTPACK RSV EIA FOR THE RAPID DETECTION OF RSV GQG ABBOTT LABORATORIES NA 34183M200

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR