BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES

    MDR report key: 14860435 · Received June 29, 2022

    Report

    Report Number
    9617032-2022-00593
    Event Type
    Malfunction
    Date Received
    June 29, 2022
    Date of Event
    June 1, 2022
    Report Date
    July 29, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE LOT #: 1293962, 1029241, 2412805, 2099517, AND 5091515 WERE REPORTED, HOWEVER, THESE LOT#¿S WERE NOT LOTS MANUFACTURED FOR THIS PRODUCT. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: MATERIAL #: 367378. LOT/BATCH #: UNKNOWN. BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR ERRONEOUS RESULTS WAS NOT OBSERVED. IN ADDITION, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THE LOT NUMBER IS UNKNOWN FOR THIS REPORTED EVENT. IN ADDITION, THE CUSTOMER HAS ACKNOWLEDGED THAT IMPROPER MIXING IS CAUSE OF THE ERRONEOUS ANALYTE. THIS COMPLAINT WILL BE REOPENED IN THE EVENT THAT THE LOT NUMBER BECOMES AVAILABLE. THIS COMPLAINT IS UNABLE TO BE CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES ERRONEOUS RESULTS FOR ELEVATED TROPONIN I VALUE. RESULTS WERE REPORTED OUT THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: THE GEL IS ALL RED WITH ERYTHROCYTES, TROPONIN VALUES OF SEVERAL LOT NUMBERS MEASURED IN THESE PLASMA TUBES IS EXTREMELY HIGH, REPEAT MEASUREMENTS FROM IDENTICAL TUBES GIVE NORMAL TROPONIN VALUES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES ERRONEOUS RESULTS FOR ELEVATED TROPONIN I VALUE. RESULTS WERE REPORTED OUT THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: THE GEL IS ALL RED WITH ERYTHROCYTES, TROPONIN VALUES OF SEVERAL LOT NUMBERS MEASURED IN THESE PLASMA TUBES IS EXTREMELY HIGH, REPEAT MEASUREMENTS FROM IDENTICAL TUBES GIVE NORMAL TROPONIN VALUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2367071 BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown