BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE BINAXNOW STREPTOCOCCUS PNEUMONIAE ANTIGEN CARD

    MDR report key: 7699644 · Received July 18, 2018

    Report

    Report Number
    1221359-2018-00473
    Event Type
    Malfunction
    Date Received
    July 18, 2018
    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
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ALERE (B)(4) ON RETAINED DEVICE LOT 905495 ASSOCIATED WITH KIT LOT E05496 WITH PRESUMED NEGATIVE URINE SAMPLES AND LOW POSITIVE CONTROLS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING BATCH RECORDS FOR LOT 905495 WERE REVIEWED. THIS LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE RELATED TO LOT NUMBER 905495 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 A FEW CASES IN WHICH PNEUMOCOCCUS WAS PRESENT IN THE BLOOD CULTURE BUT THE ALERE BINAXNOW STREPTOCOCCUS PNEUMONIAE ANTIGEN CARD TEST WAS NEGATIVE. THE DATE OR DATES OCCURENCE AND THE EXACT NUMBER OF PATIENTS OR TESTS INVOLVED IS UNKNOWN. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THE SAMPLE TYPE AND PATIENT(S) OUTCOME ARE UNKNOWN. IN A WORST CASE SCENARIO THE FALSE NEGATIVE RESULTS COULD HAVE OCCURRED IN CEREBRAL SPINAL FLUID (CSF). A FALSE NEGATIVE RESULT MAY CAUSE A DELAY IN THE PATIENT RECEIVING APPROPRIATE THERAPY. AS MENINGITIS IS A SERIOUS, LIFETHREATENING 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
    542754 ALERE BINAXNOW STREPTOCOCCUS PNEUMONIAE ANTIGEN CARD ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP GTZ ALERE SCARBOROUGH INC. E05496

    Patients

    Seq Age Sex Outcome Treatment
    1