BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISETYPE HEA MOLECULAR BEADCHIP KIT

    MDR report key: 16956398 · Received May 18, 2023

    Report

    Report Number
    3005967741-2023-00002
    Event Type
    Malfunction
    Date Received
    May 18, 2023
    Date of Event
    April 21, 2023
    Report Date
    November 9, 2023
    Manufacturer
    BIOARRAY SOLUTIONS, LIMITED
    Product Code
    PEP
    UDI-DI
    10888234100065
    PMA / PMN Number
    BP130026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 09NOV2023, UPDATED MDR WITH FOLLOW-UP 002 ADDRESSING THE ADDITIONAL INFORMATION FROM THE FDA FOR MISSING RESULTS OF THE INVESTIGATION. THE REQUESTED INVESTIGATION FINDINGS, CONCLUSION AND HEALTH IMPACT ASSESMENT HAVE BEEN UPDATED ACCORDINGLY.

    Description of Event or Problem · 0

    CUSTOMER INQUIRED ABOUT AN INDETERMINED CALL ( IC) ON A RUN. UPON REVIEW, IC IS ON V ANTIGEN. CUSTOMER REPEATED THE SAMPLE AND GOT A NEGATIVE RESULT FOR V ANTIGEN. THEY DID FURTHER INVESTIGATION AND DETERMINED THE SAMPLE HAD BEEN PREVIOUSLY TESTED IN (B)(6) 2021, WHICH HAD A POSITIVE RESULT FOR V ANTIGEN. ONLY KNOWN PATIENT HISTORY IS SICKLE CELL (SCD), NO HISTORY OF TRANSPLANT.

    Description of Event or Problem · 0

    CUSTOMER INQUIRED ABOUT AN INDETERMINED CALL ( IC) ON A RUN. UPON REVIEW, IC IS ON V ANTIGEN. CUSTOMER REPEATED THE SAMPLE AND GOT A NEGATIVE RESULT FOR V ANTIGEN. THEY DID FURTHER INVESTIGATION AND DETERMINED THE SAMPLE HAD BEEN PREVIOUSLY TESTED IN (B)(6) 2021, WHICH HAD A POSITIVE RESULT FOR V ANTIGEN. ONLY KNOWN PATIENT HISTORY IS SICKLE CELL (SCD), NO HISTORY OF TRANSPLANT.

    Description of Event or Problem · 0

    CUSTOMER INQUIRED ABOUT AN INDETERMINED CALL ( IC) ON A RUN. UPON REVIEW, IC IS ON V ANTIGEN. CUSTOMER REPEATED THE SAMPLE AND GOT A NEGATIVE RESULT FOR V ANTIGEN. THEY DID FURTHER INVESTIGATION AND DETERMINED THE SAMPLE HAD BEEN PREVIOUSLY TESTED IN (B)(6) 2021, WHICH HAD A POSITIVE RESULT FOR V ANTIGEN. ONLY KNOWN PATIENT HISTORY IS SICKLE CELL (SCD), NO HISTORY OF TRANSPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1696057 PRECISETYPE HEA MOLECULAR BEADCHIP KIT PRECISETYPE HEA BEADCHIP KIT PEP BIOARRAY SOLUTIONS, LIMITED 800-20202-08 22-118-V 10888234100065

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown