BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE BINAXNOW STREPTOCOCCUS PNEUMONIAE ANTIGEN CARD

    MDR report key: 7065525 · Received November 28, 2017

    Report

    Report Number
    1221359-2017-00009
    Event Type
    Malfunction
    Date Received
    November 28, 2017
    Date of Event
    October 26, 2017
    Report Date
    October 26, 2017
    Manufacturer
    ALERE SCARBOROUGH, INC.
    Product Code
    GTZ
    PMA / PMN Number
    K012521
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NEW INFORMATION: ADDITIONAL TESTING HAS BEEN PERFORMED SINCE INITIAL REPORT. LISTERIA MONOCYTOGENES WAS PREVIOUSLY TESTED AND WAS CONFIRMED THAT IT DID NOT CROSS-REACT WITH THE ALERE BINAXNOW STREPTOCOCCUS PNEUMONIAE ANTIGEN CARD. HOWEVER, ALERE (B)(4), INC. CONDUCTED ADDITIONAL CROSS-REACTIVITY TESTING TO SUPPORT INVESTIGATION INTO THIS COMPLAINT. THE ADDITIONAL STUDY WAS DESIGNED UTILIZING ARTIFICIAL CEREBRAL SPINAL FLUID SPIKED WITH THE FOLLOWING LISTERIA STRAINS: SEROTYPE 1/2B, ATCC: BAA-2658, SEROTYPE 4B, ATCC: 19115, SEROTYPE 3, ATCC: 19113, SEROVAR 3A, ATCC: 51782, SEROTYPE 1, ATCC: 19111, SEROVAR 1/2C, ATCC: 51779, SEROTYPE 4D, ATCC: 19117. N=5 DEVICES WERE TESTED FOR EACH STRAIN AT A CONCENTRATION OF 1 X 10^7 CELLS/TEST IN ARTIFICIAL CSF. NO CROSS-REACTIVITY WAS OBSERVED FOR ANY STRAIN USING A CURRENT LOT OF ALERE BINAXNOW STREPTOCOCCUS PNEUMONIAE ANTIGEN CARD. AT THIS TIME, THERE IS CURRENTLY NO EVIDENCE THAT THE PRODUCT IS NOT PERFORMING ACCORDING TO THE STATED SENSITIVITY AND SPECIFICITY CLAIMS.

    Additional Manufacturer Narrative · 1

    DEVICE KIT LOTS USED INCLUDE: E05711 - MANUFACTURED 02/01/2017, EXPIRES 12/31/2018. E05738 - MANUFACTURED 02/09/2017, EXPIRES 10/31/2018. THERE ARE NO SIMILAR CASES OF FALSE POSITIVE RESULTS WITH CSF FOR KIT LOTS E05711 AND E05738 THAT ALERE (B)(4) IS AWARE OF. THE QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR BOTH LOTS OF DEVICES AND THERE WERE NO NOTES REGARDING FALSE POSITIVE RESULTS. ALL QC TESTS WERE VALID AND PERFORMED WITHIN SPECIFICATIONS. TESTING WITH CEREBRAL SPINAL FLUID POSITIVE AND CEREBRAL SPINAL FLUID NEGATIVE SAMPLES DEMONSTRATED EXPECTED RESULTS WHEN READ VISUALLY AND WITH THE DEVICE COMPATIBLE ALERE READER FOR BOTH RESULTS. REVIEW OF COMPLAINT CASES RELATED TO THESE LOTS REVEALED NO SIMILAR CASES RELATED TO FALSE POSITIVE RESULTS WITH CEREBRAL SPINAL FLUID SAMPLES WHEN DEVICES WERE READ VISUALLY (WITHOUT THE ALERE READER). THE CURRENT COMPLAINT RATE FOR THE DISTRIBUTED DEVICE LOTS E05711 AND E05738 ARE (B)(4). THE PHOTOGRAPH OF THE CUSTOMER'S USED DEVICE (CLOSED ONLY, KIT E05711) WAS REVIEWED. IT APPEARED TO BE A VALID, POSITIVE RESULT WITH CLEARLY VISIBLE CONTROL AND SAMPLE LINES. NO BACKGROUND STAINING WAS OBSERVED. ALERE (B)(4) INTENDS TO PERFORM TESTING WITH THE CUSTOMER'S RETURNED SAMPLE X3 WITH BOTH RETAIN KIT LOTS (READ VISUALLY) WHEN RECEIVED. A FOLLOW UP REPORT WILL BE PROVIDED. ALERE (B)(4) WOULD LIKE TO NOTE THAT THE DEVICE IS NOT A STANDALONE TEST; AS DESCRIBED IN THE INTENDED USE IT IS TO BE USED IN CONJUNCTION WITH CULTURE AND OTHER METHODS TO AID IN THE DIAGNOSIS OF BOTH PNEUMOCOCCAL PNEUMONIA AND PNEUMOCOCCAL MENINGITIS. THEREFORE, THE RISK OF A FALSE POSITIVE RESULT IS MITIGATED IF FOLLOWED. AT THIS TIME, THERE IS CURRENTLY NO EVIDENCE THAT THE PRODUCT IS NOT PERFORMING ACCORDING TO THE STATED SENSITIVITY AND SPECIFICITY CLAIMS BUT THIS INCIDENT WILL CONTINUE TO BE INVESTIGATED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THREE FALSE POSITIVE RESULTS FOR ONE PATIENT WITH THE ALERE BINAXNOW STREP PNEUMONIAE TEST USING THE SAME CEREBRAL SPINAL FLUID SAMPLE. THE CUSTOMER DID NOT USE THE ALERE READER TO INTERPRET THE TESTS - THEY WERE INTERPRETED VISUALLY. THE PATIENT WAS GIVEN AN UNKNOWN TREATMENT BASED ON THE ALERE TEST RESULT AND WAS CHANGED 24-HOURS LATER AFTER CONFIRMATORY TESTING PROVED NEGATIVE FOR S. PNEUMO, BUT POSITIVE FOR LISTERIA MONOCYTOGENES. NO OTHER ADVERSE OUTCOMES WERE REPORTED - THE PATIENT REMAINED IN STABLE CONDITION SINCE FINAL DIAGNOSIS OF LISTERIA MENINGITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844714 ALERE BINAXNOW STREPTOCOCCUS PNEUMONIAE ANTIGEN CARD STREP PNEUMO ICT, BINAXNOW STREP PNEUMO TEST GTZ ALERE SCARBOROUGH, INC. E05711

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention