BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE BINAXNOW STREPTOCOCCUS PNEUMONIAE ANTIGEN CARD

    MDR report key: 6979417 · Received October 26, 2017

    Report

    Report Number
    1221359-2017-00001
    Event Type
    Malfunction
    Date Received
    October 26, 2017
    Date of Event
    June 23, 2017
    Report Date
    September 20, 2017
    Manufacturer
    ALERE SCARBOROUGH, INC.
    Product Code
    GTZ
    PMA / PMN Number
    K012521
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART NUMBER, 710-100 IS NOT DISTRIBUTED IN THE UNITED STATES AS THE EXPORTED VERSION HAS ADDITIONAL CLAIMS FOR THE USE OF THE ALERE READER, WHICH IS NOT CLEARED FOR USE WITH THIS ASSAY IN THE UNITED STATES. AS THIS CUSTOMER RECEIVED THIS TEST RESULT WITH A VISUAL READ, THIS EVENT IS SIMILAR TO PRODUCT SOLD IN THE UNITED STATES. THE CSF SPECIMEN WAS REQUESTED, BUT THERE WAS TOO SMALL OF AN AMOUNT OF CEREBRAL SPINAL FLUID RETAINED THAT COULD BE USED TO RUN ANOTHER TEST OR SENT TO ALERE FOR FURTHER INVESTIGATION. ALERE (B)(4). COMPLETED A REVIEW OF MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR DEVICE LOT 905742 AND THERE WERE NO ISSUES FOUND AND NO NOTES REGARDING FALSE POSITIVE RESULTS. ALL QC TESTS WERE VALID AND PERFORMED WITHIN SPECIFICATIONS. THE RETAIN KIT WAS TESTED WITH CSF NEGATIVE AND POSITIVE CONTROLS. ALL TESTS WERE VALID AND PERFORMED AS EXPECTED WITH NO FALSE POSITIVE RESULTS. TH RE ARE NO OTHER CSF FALSE POSITIVE RESULTS REPORTED FOR THIS LOT. THERE ARE (B)(4) TESTS DISTRIBUTED FOR THIS KIT LOT. THE COMPLAINT RATE FOR CSF FALSE POSITIVE TESTS IS (B)(4). EVIDENCE AVAILABLE DOES NOT INDICATE THAT THIS DEVICE LOT IS PERFORMING OUTSIDE OF LABEL CLAIMS.

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE CUSTOMER RECEIVED A USER-INTERPRETED (I.E., VISUALLY READ) FALSE POSITIVE RESULT WITH THE BINAXNOW STREPTOCOCCUS PNEUMONIAE ANTIGEN CARD. THE CUSTOMER RAN THE TEST USING A CEREBRAL SPINAL FLUID (CSF) SAMPLE. FOLLOWING THE POSITIVE RESULT, TREATMENT AGAINST STREPTOCOCCUS PNEUMONIAE WAS GIVEN TO THE PATIENT WITH NO IMPROVEMENT IN PATIENT STATUS. THE CUSTOMER STATED THAT "THE SITUATION WAS VERY CRITICAL AND THE PATIENT ALMOST DIED." THE CUSTOMER RAN FURTHER TESTS CONFIRMING ABSENCE OF S. PNEUMONIAE AND PRESENCE OF PSEUDOMONAS AERUGINOSA. THE CUSTOMER STATED THE INITIAL TREATMENT PROVIDED FOR S. PNEUMONIAE WAS INEFFICIENT FOR TREATING P. AERUGINOSA INFECTION AND THUS WAS ADJUSTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762045 ALERE BINAXNOW STREPTOCOCCUS PNEUMONIAE ANTIGEN CARD STREP PNEUMO ICT, BINAXNOW STREP PNEUMO TEST, PRODUCT CODE GTZ ALERE SCARBOROUGH, INC. E05753

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Unknown Other