BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT TESTPACK RSV

    MDR report key: 81016 · Received March 25, 1997

    Report

    Report Number
    1451914-1997-00018
    Event Type
    Other
    Date Received
    March 25, 1997
    Date of Event
    January 20, 1997
    Report Date
    March 25, 1997
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GQG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: NO CUSTOMER RETURN RECEIVED. FILE MATERIAL PERFORMED APPROPRIATELY MEETING ALL PERFORMANCE CRITERIA. KNOWN NEGATIVE SAMPLES YIELDED NEGATIVE RESULTS. NEGATIVES WERE CLEAR, CLEAN, AND EASY TO INTERPRET. KNOWN POSITIVES WERE PICKED UP AT APPROPRIATE LEVELS WITH BAR INTENSITIES ACCEPTABLE. IN RESPONSE TO THE CUSTOMER STATING THAT A FAINTLY POSITIVE RESULT IS INTERPRETED BY THE MAJORITY OF TECHS AS NEGATIVE, ANY COLOR ON THE VERTICAL BAR IS A POSITIVE RESULT. SINCE THE CUSTOMER DID NOT RETURN THE KIT, PATIENT SAMPLE, OR A SAMPLE OF THEIR TRANSPORT MEDIA FOR EVALUATION, FURTHER ANALYSIS CANNOT BE PERFORMED. THE COMPLAINT WAS NOT CONFIRMED. EVALUATION COMPLETE-FINAL REPORT.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THEY OBTAINED DISCREPANT RESULTS WHEN USING THE RSV KIT. THE ACCOUNT STATED THAT WHEN A RAPID ASSAY IS RUN, THE NEGATIVE ASSAYS ARE SENT TO A REFERENCE LAB FOR FA. THE METHOD OF FA IS UNKOWN. THE ACCOUNT STATED THEY HAD A INCIDENT WHICH GAVE A NEGATIVE RESULT ON THE KIT AND POSITIVE ON FA, BUT WHEN THE SAMPLE WAS REPEATED IN THE LAB IT WAS POSITIVE. THE REPORTER ATTRIBUTED THIS TO OPERTOR ERROR AS THE KIT WAS ALLOWED TO SIT OUT AT ROOM TEMPERATURE FOR 5-10 MINUTES BEFORE USE. LABEL STATES KIT REAGENTS AND REACTION DISCS MUST BE AT ROOM TEMPERATURE PRIOR TO USE (MINIMUM 30 MINUTES). ADDITIONAL INFO INDICATES THEY HAD ANOTHER SAMPLE WHICH WAS NEGATIVE ON THE KIT AND POSITIVE WITH FA. ONE PT WAS A BABY ADMITTED WITH UPPER RESPIRATORY PROBLEMS. THE NEGATIVE RESULT FROM RSV KIT IMPACTED PT SINCE TREATMENT WAS DELAYED FOR ABOUT 24 HOURS UNTIL FA RESULT RECEIVED AND PT WAS NOT TREATED OR ISOLATED. NO ADDITIONAL INFO ON PTS AVAILABLE DUE TO CONFIDENTIALITY ISSUES.

    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 24251M100

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other