BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD KIESTRA READA COMPACT

    MDR report key: 22243466 · Received June 17, 2025

    Report

    Report Number
    3010141591-2025-00002
    Event Type
    Malfunction
    Date Received
    June 17, 2025
    Date of Event
    May 27, 2025
    Report Date
    June 19, 2025
    Manufacturer
    BD KIESTRA LAB AUTOMATION
    Product Code
    JTQ
    UDI-DI
    00382904472061
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 3010141591-2025-00002 WAS SENT IN ERROR. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. THEREFORE, THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. D.4. MEDICAL DEVICE EXPIRATION DATE: N/A.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD KIESTRA READA COMPACT HAS BEEN FOUND CONTRIBUTING TO ERRONEOUS PATIENT RESULTS. NO PATIENT IMPACT WAS REPORTED.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD KIESTRA READ A COMPACT HAS BEEN FOUND CONTRIBUTING TO ERRONEOUS PATIENT RESULTS. NO PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37509 BD KIESTRA READA COMPACT BATH, INCUBATORS/WATER, ALL JTQ BD KIESTRA LAB AUTOMATION 00382904472061

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other