BEUDAMED
    FDA Adverse Event Death Summary report: N

    BINAXNOW LEGIONELLA 22T (LFR)

    MDR report key: 16326894 · Received February 8, 2023

    Report

    Report Number
    1221359-2023-00247
    Event Type
    Death
    Date Received
    February 8, 2023
    Date of Event
    December 28, 2022
    Report Date
    February 8, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    MJH
    PMA / PMN Number
    K070522
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION THE DATE OF DEATH WAS ASKED BUT IS UNKNOWN. THE DATE PROVIDED IN THIS FIELD IS AN APPROXIMATION. MEDICAL OPINION AND INVESTIGATION SUMMARY BASED ON AVAILABLE INFORMATION, IT APPEARS THAT THE PRIMARY REASON FOR THE PATIENT¿S ADMISSION TO HOSPITAL WAS DUE TO THE LEGIONELLA DIAGNOSIS, WHICH THEN TURNED OUT TO BE FALSE POSITIVE (FP) BASED ON A NEGATIVE CONFIRMATORY PCR TEST RESULT. COMPLICATING THE CLINICAL PRESENTATION IS THAT THERE IS EVIDENCE THAT THE PATIENT ALSO CONCOMITANTLY TESTED POSITIVE FOR COVID-19. HOWEVER, BASED ON THE FACT THAT PATIENT WAS PUT ON LEGIONELLA TREATMENT SUGGESTS THAT A DIAGNOSIS OF LEGIONELLA WAS THE OVERRIDING REASON FOR ADMISSION TO THE HOSPITAL. THE ADMISSION TO HOSPITAL LED TO THE DEVELOPMENT OF HAP SO THE FP IS AT MINIMUM A LIKELY CONTRIBUTORY FACTOR LEADING TO THE PATIENT¿S OUTCOME. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 185560 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR KIT PART NUMBER 852-100 / LOT 185560 AND DEVICE PART NUMBER 852-430R/ LOT 911275. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH DID NOT IDENTIFY A PRODUCT DEFICIENCY. THE RETENTION TESTING YIELDED EXPECTED RESULTS WHEN TESTING INTERNAL QC SAMPLES, THE BATCH HISTORY RECORD REVIEW (BHR) REVEALED THAT THE PRODUCT MET ACCEPTANCE CRITERIA FOR RELEASE, AND REVIEW OF COMPLAINT TRENDS AGAINST THE KIT LOT FOR THE REPORTED ISSUE INDICATES THE PRODUCT IS PERFORMING WITHIN EXPECTED CLAIMS IN THE CURRENT REVISION OF THE PACKAGE INSERT. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE, HOWEVER IT COULD HAVE POSSIBLY BEEN RELATED TO THE SPECIFIC PATIENT SAMPLE. A FOLLOW-UP REPORT WILL BE SENT IF ANY ADDITIONAL INFORMATION IS RECEIVED. SINGLE USE DEVICE; DISCARDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW LEGIONELLA 22T (LFR) USING A URINE SAMPLE ON (B)(6) 2022. THE REFERENCE LABORATORY TESTED THE SAME SAMPLE ON THE BARTELS ELISA AND THEN BY BINAX ELISA AND BOTH TESTS WERE NEGATIVE. THE PATIENT WAS GIVEN ANTIBIOTICS TO TREAT LEGIONELLA DUE TO THE POSITIVE RESULT. PIPERACILLIN TAZOBACTAM WAS SWITCHED TO LEVOFLOXACIN AND PER THE CUSTOMER, ¿THIS WAS TO COVER FOR BOTH LEGIONELLA AND AN ALTERNATIVE TREATMENT FOR HOSPITAL-ACQUIRED PNEUMONIA (HAP).¿ THE PATIENT ALSO TESTED POSITIVE FOR COVID-19 AT THE TIME OF TESTING FOR LEGIONELLA. THE CUSTOMER REPORTED THAT THE PATIENT EXPIRED WHILE AT THE HOSPITAL (DATE OF DEATH UNKNOWN) AND THAT THE CAUSE WAS "LIKELY SECONDARY TO HAP / COVID PNEUMONITIS". THE CUSTOMER ALSO REPORTED THAT THERE WERE NO RISK FACTORS FOR LEGIONELLA PNEUMONIA, OTHER THAN AGE. NO ADDITIONAL INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2175311 BINAXNOW LEGIONELLA 22T (LFR) IVD FOR LEGIONELLA MJH ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 185560

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Female Death