BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD¿ TUBES

    MDR report key: 8972270 · Received September 6, 2019

    Report

    Report Number
    2243072-2019-01946
    Event Type
    Malfunction
    Date Received
    September 6, 2019
    Date of Event
    August 6, 2019
    Report Date
    September 13, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAD REACHED OUT TO THE CUSTOMER IN ORDER TO GATHER MORE INFORMATION ON THE CATALOG AND LOT NUMBER; HOWEVER, THE CUSTOMER INDICATED THAT THIS INFORMATION WAS NOT AVAILABLE. A GOOD FAITH EFFORT HAS BEEN MADE AND THIS COMPLAINT WILL BE CLOSED WITHOUT FURTHER INVESTIGATION AT THIS TIME. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THIS COMPLAINT WILL BE REOPENED TO ASSESS THE LEVEL OF INVESTIGATION NEEDED. H3 OTHER TEXT : SEE SECTION H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UNSPECIFIED BD¿ TUBES WERE GIVING ERRONEOUS RESULTS. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. UNKNOWN BATCH NO. UNKNOWN IT WAS REPORTED THAT INTERFERENCES WERE MADE FOLLOWING STORAGE IN SERUM SEPARATOR TUBES. AT THE CONFERENCE, AN ASSOCIATE IDENTIFIED POSTER IMPACT OF INTERFERENCES FROM SERUM SEPARATOR TUBES ON STEROID HORMONE MEASUREMENTS BY HIGH PERFORMANCE LIQUID CHROMATOGRAPHY TANDEM MASS SPECTROMETRY (UHPLC-MS/MS), WHICH STATES THAT PROGESTERONE BECAME UNQUANTIFIABLE DUE TO A SIGNIFICANT INTERFERENCE PEAK USING ULTRA-HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (UHPLC-MS/MS) FOLLOWING STORAGE IN BD VACUTAINER® SST TUBES. IN ADDITION, A REVIEW OF ABSTRACT PAPER, STATES THE FOLLOWING INTERFERENCES OF MEASUREMENTS BY ULTRA-HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (UHPLC-MS/MS) FOLLOWING STORAGE IN SERUM SEPARATOR TUBE TYPES: (DECREASES IN ESTRONE / ESTRONE SULFATE, INCREASES IN TESTOSTERONE, DHEAS AND ESTRADIOL).

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. INITIAL REPORTER FACILITY: THE USER FACILITY ADDRESS IS NOT AVAILABLE, THE CORPORATE HEADQUARTERS INFORMATION WAS USED INSTEAD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UNSPECIFIED BD¿ TUBES WERE GIVING ERRONEOUS RESULTS. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. UNKNOWN, BATCH NO. UNKNOWN. IT WAS REPORTED THAT INTERFERENCES WERE MADE FOLLOWING STORAGE IN SERUM SEPARATOR TUBES. AT THE CONFERENCE, AN ASSOCIATE IDENTIFIED POSTER IMPACT OF INTERFERENCES FROM SERUM SEPARATOR TUBES ON STEROID HORMONE MEASUREMENTS BY HIGH PERFORMANCE LIQUID CHROMATOGRAPHY TANDEM MASS SPECTROMETRY (UHPLC-MS/MS), WHICH STATES THAT PROGESTERONE BECAME UNQUANTIFIABLE DUE TO A SIGNIFICANT INTERFERENCE PEAK USING ULTRA-HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (UHPLC-MS/MS) FOLLOWING STORAGE IN BD VACUTAINER® SST TUBES. IN ADDITION, A REVIEW OF ABSTRACT PAPER, STATES THE FOLLOWING INTERFERENCES OF MEASUREMENTS BY ULTRA-HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (UHPLC-MS/MS) FOLLOWING STORAGE IN SERUM SEPARATOR TUBE TYPES: (DECREASES IN ESTRONE / ESTRONE SULFATE, INCREASES IN TESTOSTERONE, DHEAS AND ESTRADIOL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764829 UNSPECIFIED BD¿ TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other