BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE BINAXNOW STREPTOCOCCUS PNEUMONIAE ANTIGEN CARD

    MDR report key: 7699633 · Received July 18, 2018

    Report

    Report Number
    1221359-2018-00478
    Event Type
    Malfunction
    Date Received
    July 18, 2018
    Date of Event
    June 20, 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
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ALERE (B)(4) ON RETAINED DEVICE LOT E04180 ASSOCIATED WITH KIT LOT E04568 WITH A LOW POSITIVE AND A NEGATIVE CONTROL. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING BATCH RECORDS FOR LOT E04180 WERE REVIEWED. THIS LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE RELATED TO LOT NUMBER E04180 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

    THIS REPORT REPRESENT 3 OF AT LEAST THREE 3 FALSE NEGATIVE ALERE BINAXNOW STREPTOCOCCUS PNEUMONIAE ANTIGEN CARD PATIENT TEST RESULTS REPORTED BY A CUSTOMER. CULTURES WERE REPORTED POSITIVE AND ONE OF THE SAMPLES WAS ALSO POSITIVE BY A FLUORESCENCE METHOD. THE EXACT NUMBER OF PATIENTS INVOLVED IS UNKNOWN. THE SAMPLE TYPE AND PATIENT(S) OUTCOME ARE UNKNOWN. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. IN A WORST-CASE SCENARIO, A REPORTED FALSE NEGATIVE RESULT OCCURRED AND A CEREBRAL SPINAL FLUID (CSF) MAY HAVE BEEN USED. 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
    542411 ALERE BINAXNOW STREPTOCOCCUS PNEUMONIAE ANTIGEN CARD ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP GTZ ALERE SCARBOROUGH INC. E04568

    Patients

    Seq Age Sex Outcome Treatment
    1