BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE BINAXNOW STREPTOCOCCUS PNEUMONIAE ANTIGEN CARD

    MDR report key: 7699625 · Received July 18, 2018

    Report

    Report Number
    1221359-2018-00474
    Event Type
    Malfunction
    Date Received
    July 18, 2018
    Date of Event
    November 28, 2016
    Report Date
    July 18, 2018
    Manufacturer
    ALERE SCARBOROUGH INC.
    Product Code
    GTZ
    PMA / PMN Number
    K012521
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ALERE (B)(4) ON RETAINED DEVICE LOT 905077 ASSOCIATED WITH KIT LOT E05116 WITH CEREBRAL SPINAL FLUID NEGATIVE AND POSITIVE QUALITY CONTROLS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING BATCH RECORDS FOR LOT 905077 WERE REVIEWED. THIS LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE RELATED TO LOT NUMBER 905077 SHOWED NO SIMILAR COMPLAINTS. THE EVIDENCE AVAILABLE DOES NOT INDICATE THAT THE PRODUCT IS PERFORMING OUTSIDE LABEL CLAIMS. ALERE (B)(4) WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. THE AVAILABLE EVIDENCE SUGGESTS THAT THIS DEVICE LOT IS PERFORMING WITHIN LABELED CLAIMS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT TWO CEREBRAL SPINAL FLUID (CSF) SAMPLES COLLECTED FROM THE SAME PATIENT ON TWO DIFFERENT DAYS AND TESTED WITH THE ALERE BINAXNOW STREPTOCOCCUS PNEUMONIAE ANTIGEN CARD TEST WERE NEGATIVE. THE CSF SAMPLE WAS POSITIVE GRAM COLORATION AND POSITIVE CULTURE AFTER 8 HOURS. THE SAMPLE WAS SENT TO THE NATIONAL REFERENCE LAB FOR CONFIRMATION TESTING AND IT WAS POSITIVE FOR S. PNEUMONIAE SEROTYPE 3. A FALSE NEGATIVE RESULT MAY CAUSE A DELAY IN THE PATIENT RECEIVING APPROPRIATE THERAPY. AS MENINGITIS IS A SERIOUS, LIFE THREATENING CONDITION DELAYS IN TREATMENT MAY HAVE SEVERE CONSEQUENCES; THEREFORE, THIS IS A REPORTABLE EVENT. THIS MDR IS A RETROSPECTIVE FILING IN RESPONSE TO AN OBSERVATION FROM AN FDA INSPECTION CONDUCTED FEBRUARY 26TH TO MARCH 2ND , 2018 AT ALERE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542239 ALERE BINAXNOW STREPTOCOCCUS PNEUMONIAE ANTIGEN CARD ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP GTZ ALERE SCARBOROUGH INC. E05116

    Patients

    Seq Age Sex Outcome Treatment
    1