BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW LEGIONELLA 22T (LFR)

    MDR report key: 21279042 · Received January 30, 2025

    Report

    Report Number
    1221359-2025-00028
    Event Type
    Malfunction
    Date Received
    January 30, 2025
    Date of Event
    January 21, 2025
    Report Date
    January 30, 2025
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    MJH
    UDI-DI
    10811877011047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4 - PMA/510(K)#: THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 852-100 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER: 852-000. ABBOTT MEDICAL AFFAIRS WAS CONSULTED FOR A MEDICAL EVALUATION IN REGARD TO THE REPORTED EVENT AND INDICATED THAT WITH THE LIMITED INFORMATION PROVIDED, IT IS NOT POSSIBLE TO KNOW IF THE DEVICE MALFUNCTIONED, AND IF SO, IF IT COULD HAVE CONTRIBUTED TO THE PATIENT'S DEATH. ACCORDING TO CUSTOMER, THEY ASSUME THAT THE PRODUCT IS WORKING PROPERLY. IN ADDITION, THEY DID NOT CONSIDER THAT THE PRODUCT HAD ANY IMPACT ON THE TREATMENT AND TO THE PATIENT'S DEATH. THEY INFORMED THAT THE PATIENT WAS NOT HOSPITALIZED WITH SIGNS AND SYMPTOMS OF LEGIONELLA. THE MEDICAL EVALUATION CONCLUDED THIS EVENT AS A MALFUNCTION OF THE DEVICE, AS CONFLICTING RESULTS WERE REPORTED. HOWEVER, IF THE PATIENT DIED 7 HOURS AFTER A POSSIBLE DIAGNOSIS AND TREATMENT, THE CONDITIONS MUST HAVE BEEN VERY BAD AND PROBABLY THE POSSIBLE FALSE TEST RESULT IS NOT RESPONSIBLE FOR THE PATIENT'S DEATH SINCE THE EVOLUTION TO THE PATIENT'S DEATH WAS VERY FAST AND THERE IS NOT ENOUGH TIME FOR THE TREATMENT TO HAVE ANY EFFECT. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT: 864864 WITH INTERNAL POSITIVE AND NEGATIVE QUALITY CONTROL SAMPLES. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR TEST KIT PART NUMBER: 852-100/LOT: 864864 AND DEVICE PART NUMBER: 852-430R/LOT: 855465. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT: 864864 SHOWED THAT THE COMPLAINT RATE IS (B)(4). A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT: 864864 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. HOWEVER, IT COULD HAVE POSSIBLY BEEN RELATED TO THE SPECIFIC PATIENT SAMPLE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A CONFLICTING RESULT WITH THE BINAXNOW LEGIONELLA 22T ASSAY ON (B)(6) 2025. THE FIRST TEST ADMINISTERED PROVIDED A POSITIVE RESULT. THE SECOND TEST WAS ADMINISTERED 7 HOURS LATER AND RETURNED A NEGATIVE RESULT. THE CUSTOMER REPORTED THAT THE PATIENT HAS PASSED AWAY AFTER THE CONFLICTING RESULTS. THE CUSTOMER CONFIRMED THAT THE PRODUCT WAS NOT ATTRIBUTED TO THE DEATH OF THE PATIENT. THE PATIENT WAS NOT ADMITTED TO HOSPITAL WITH SIGNS AND SYMPTOMS OF LEGIONELLA. ACCORDING TO THE CUSTOMER¿S TESTIMONY, THEY BELIEVE THE PRODUCT IS FUNCTIONING PROPERLY. THEY DO NOT BELIEVE THAT THE PRODUCT HAD ANY IMPACT ON THE TREATMENT AND COURSE OF THE PATIENT¿S CASE AND ASSUMES THAT THE PRODUCT IS FUNCTIONING PROPERLY. THE CUSTOMER'S REQUEST WAS TO ASSIST WITH THEIR ASSESSMENT OF THE CONFLICTING RESULTS WITH REGARDS TO HOSPITAL HYGIENE FACTORS AND DOES NOT BELIEVE THAT ABBOTT'S PRODUCT HAD ANY IMPACT ON THE TREATMENT AND COURSE OF THE PATIENT'S CASE AS A PALLIATIVE SITUATION. ALTHOUGH REQUESTED, THE CUSTOMER INDICATED THAT NO FURTHER INFORMATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520228 BINAXNOW LEGIONELLA 22T (LFR) LEGIONELLA, SPP., ELISA MJH ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 864864 10811877011047

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death