BEUDAMED
    FDA Adverse Event Other Summary report: N

    HIVAB HIV-1/HIV-2 (RDNA) EIA

    MDR report key: 98514 · Received June 13, 1997

    Report

    Report Number
    1415939-1997-00013
    Event Type
    Other
    Date Received
    June 13, 1997
    Date of Event
    March 7, 1997
    Report Date
    June 11, 1997
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LRM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CODE 86, 200, 68: NO PT SAMPLE WAS RETURNED. THE LOT # THE CUSTOMER USED TO TEST THE SAMPLE IS UNK. THE PT SAMPLE WAS TESTED BY THE CUSTOMER ON 3/7/97 THEREFORE DMS DATA WAS REVIEWED FOR LOTS USED BETWEEN 2/97 AND 4/97. DMS DATA INDICATED THAT INITIAL AND REPEAT REACTIVE RATES WERE WITHIN PACKAGE INSERT CRITERIA. THIS THE FINAL REPORT.

    Description of Event or Problem · 1

    PT (NEWBORN) WAS PLACED ON PROPHYLACTIC AZT FROM 3/7/97 TO 3/14/97 AS A RESULT OF THE MOTHER TESTING POSITIVE FOR HIV 1/2 EIA AT DELIVERY. SAMPLE FROM MOTHER WAS REPEAT REACTIVE FOR HIV 1/2 EIA BUT WESTERN BLOT WAS NEGATIVE. CONFIRMATORY TESTING BY WESTERN BLOT AND IMMUNOBLOT PERFORMED BY REFERENCE LABORATORY. PT WEIGHT UNAVAILABLE. NO FURTHER PT INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIVAB HIV-1/HIV-2 (RDNA) EIA EIA FOR DETECTION OF AB TO HIV I AN II LRM ABBOTT LABORATORIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY Other