BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEAR VIEW STREP DETECTION

    MDR report key: 146484 · Received January 30, 1998

    Report

    Report Number
    MW1012898
    Event Type
    Malfunction
    Date Received
    January 30, 1998
    Date of Event
    January 1, 1998
    Report Date
    January 30, 1998
    Manufacturer
    WAMPOLE LABORATORIES
    Product Code
    JTO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE RPTR WORKS FOR THE DEPT OF HLTH INSPECTING LABS FOR COMPLIANCE WITH CLIA AND STATE CLINICAL LAB REGULATIONS. SHE REC'D A CALL FROM A PEDIATRIC LAB IN HER JURISDICTION. THE LAB WAS CALLING TO REPORT A 15% FALSE POSITIVE RATE FOR THE DEVICE LOTS WHICH ARE LISTED. THE LAB DOES A DIRECT ANTIGEN TEST AS WELL AS A THROAT CULTURE ON EACH PT. THE RPTR NOTES THAT THE LAB WAS IN COMPLIANCE ON ITS LAST INSPECTION AND SHE FEELS THE INFO BEING REPORTED IS RELIABLE SINCE THE LAB ROUTINELY PERFORMS CULTURES. THE LAB INITIALLY CONTACTED THE MFR WITH THEIR CONCERNS, BUT WERE TOLD THERE WERE NO PROBLEMS WITH THESE LOTS. THE LAB PROCEEDED TO RETURN THE LOTS TO THE MFR AND CONTACT THE STATE DEPT OF HLTH. AFTER RECEIVING THE DEVICES, THE MFR CONFIRMED THAT "PROBLEMS" EXISTED WITH THESE LOTS. THE DEVICES ARE REPORTEDLY MFG IN ANOTHER COUNTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEAR VIEW STREP DETECTION LABORATORY TEST JTO WAMPOLE LABORATORIES UNK 1380,1387

    Patients

    Seq Age Sex Outcome Treatment
    1 NA