BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT TESTPACK RSV

    MDR report key: 113491 · Received June 16, 1997

    Report

    Report Number
    1451914-1997-00028
    Event Type
    Other
    Date Received
    June 16, 1997
    Date of Event
    April 24, 1997
    Report Date
    June 13, 1997
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GQG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ON 4/23/97, THE ACCOUNT REPORTED A NEGATIVE RESULT FOR THE TESTPACK RSV ASSAY ON A PT SAMPLE. ACCORDING TO THE ACCOUNT, THE INFANT HAD INGESTED 2 OZ. OF SIMILAC TO PRIOR TO OBTAINING THE NASPHARYNGEAL WASH SPECIMEN. THE PT WAS DISCHARGED FROM THE HOSPITAL ON 4/25/97 AND ADMITTED TO ANOTHER HOSPITAL ON 4/27/97. A NEW SPECIMEN, OBTAINED AT THE OTHER HOSPITAL, TESTED POSITIVE WITH RSV TESTPACK KIT, LOT 26838M200. THE PT WAS TREATED FOR RSV ON 4/28/97 AND DISCHARGED FROM THE HOSPITAL. NO REPORT OF INJURY. A POSITIVE RESULT WAS RECEIVED WHEN THE SAMPLE WAS FIRST TESTED. THE SAMPLE WAS RECEIVED IN A SALINE TRANSPORT MEDIA. SALINE WAS USED AS A NEGATIVE CONTROL AND PERFORMED AS EXPECTED. THE KIT IS STORED AT 2-8C AND ALLOWED TO WARM FOR 1 HOUR BEFORE USE. ACCORDING TO THE ACCOUNT, THE "+" INDICATOR ON THE PT SAMPLE APPEARED TO BE GREEN IN COLOR AND THE ACCOUNT WAS USE TO SEEING THE "+" INDICATOR AS PURPLE, AND INTERPRETTED THE RESULT AS INVALID. REPEAT TESTING OF THE SAMPLE GAVE A NEGATIVE RESULT, WHICH WAS REPORTED.

    Description of Event or Problem · 2

    ON 4/24/97, THE ACCOUNT REPORTED A DISCREPANT RESULT FOR THE TESTPACK RSV ASSAY. THE PT WAS ORIGINALLY TESTED ON 3/31/97 AT THIS HOSPITAL WITH TESTPACK RSV KIT, LOT 24269M100, EXPIRATION DATE 10/30/97, AND A POSITIVE RESULT WAS REPORTED. AT THAT TIME, THE PHYSICIAN DECIDED NOT TO TREAT THE PT BASED ON CLINICAL SYMPTOMS. THE PT WAS READMITTED ON 4/27/97 WHEN THE NEGATIVE RESULTS WERE RECEIVED FROM A NASOPHARYNGEAL WAS COLLECTED THAT DAY. THE PHYSICIAN FELT THE PT SHOULD STILL BE POSITIVE, AS HE HAD NOT PREVIOUSLY RECEIVED TREATMENT FOR RSV. THE PT HAS BEEN DISCHARGED FROM THE HOSPITAL. NO REPORT OF INJURY. A POSITIVE RESULT WAS RECEIVED WHEN THE SAMPLE WAS FIRST TESTED. THE SAMPLE WAS RECEIVED IN A SALINE TRANSPORT MEDIA. SALINE, USED AS A NEGATIVE CONTROL, PERFORMED AS EXPECTED. ACCORDING TO THE ACCOUNT, THE "+" INDICATOR ON THE PT SAMPLE APPEARED TO BE GREEN IN COLOR INSTEAD OF PURPLE, WHICH THE ACCOUNT WAS USE TO SEEING, AND INTERPRETTED THE RESULT AS INVALID. REPEAT TESTING OF THE SAMPLE GAVE A NEGATIVE RESULT, WHICH WAS REPORTED.

    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 24375M400

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Other
    2 5 MO Other