BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD TUBE PMS PLH 13X100 3.5 PLBL LIM CE

    MDR report key: 15898182 · Received December 1, 2022

    Report

    Report Number
    9617032-2022-01221
    Event Type
    Malfunction
    Date Received
    December 1, 2022
    Date of Event
    November 10, 2022
    Report Date
    December 2, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1229003, MEDICAL DEVICE EXPIRATION DATE: 2022-12-31, DEVICE MANUFACTURE DATE: 2021-08-17. MEDICAL DEVICE LOT #: 2192112, MEDICAL DEVICE EXPIRATION DATE: 2023-11-30, DEVICE MANUFACTURE DATE: 2022-07-11. MEDICAL DEVICE LOT #: 1131899, MEDICAL DEVICE EXPIRATION DATE: 2022-09-30, DEVICE MANUFACTURE DATE: 2021-05-11. MEDICAL DEVICE LOT #: 1256747, MEDICAL DEVICE EXPIRATION DATE: 2023-01-31, DEVICE MANUFACTURE DATE: 2021-09-13. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B.5 DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED WHEN USING THE BD TUBE PMS PLH 13X100 3.5 PLBL LIM CE THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD AND ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WE NOTICE THAT SOME BARRICOR TUBES ARE NOT FILLED PROPERLY. THE CURRENT BATCH OF BARRICOR TUBES ARE 1229003 EXP 31/12/22 , 2192112 EXP 30/11/23 , 1131899 EXP 30/09/22 , 1256747 EXP 2023." ADDITIONAL INFO FROM TASK RECEIVED 15DEC2022: 12/11/22: TELEPHONE CALL FROM AN EMERGENCY DOCTOR WITH UNEXPLAINED HYPOKALEMIA AND ADDS THAT OTHER COLLEAGUES HAVE BEEN EXPERIENCING UNWARRANTED UNJUSTIFIED HYPOKALEMIA FOR SOME TIME. WE COMPARED K+ ON COBAS PRO (BARRICOR) OF THE PATIENTS OF 10/11 AND 12/11 WITH THEIR K+ ON BLOOD GAS SYRINGE, THE CORRELATION COEFFICIENT IS 0.91. WE OBSERVE SOME DIFFERENCES BETWEEN THE TWO AUTOMATS. ANNEX A CODE: A0908. H.6. INVESTIGATION SUMMARY: MATERIAL #: 365053. LOT/BATCH #: 1229003, 2192112, 1256747, 1131899. BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR UNDERFILL WAS OBSERVED. ERRONEOUS RESULTS CANNOT BE EVALUATED THROUGH PHOTOS. ADDITIONALLY, RETENTION SAMPLES OF THE INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, THE INDICATED FAILURE MODE FOR UNDERFILL WAS NOT OBSERVED. 20 RETAINED SAMPLES FROM EACH LOT NUMBERS: 1229003; 2192112; 1256747 WERE DRAW-TESTED. FROM THIS TESTING, IT WAS DETERMINED THAT ALL 60 TUBES DREW WITHIN SPECIFICATION. LOT 1131899 EXPIRED 30TH OF SEPTEMBER 2022 AND COULD NOT BE TESTED. FURTHER CLINICAL TESTING WAS COMPLETED ON LOT #'S 2192112 AND 1256747. LOT #'S 1229003 AND 1131899 WERE BEYOND THE DATE OF EXPIRATION AT THE TIME OF TESTING. NO DIFFICULTIES WERE ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES EXHIBITED PROPER FILL. BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE OF ERRONEOUS RESULTS-LOW POTASSIUM, AS THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. REPLICATES OF BOTH RETAINS AND CONTROL SAMPLES TESTED DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE FOR ALL VISUAL OBSERVATIONS AND TESTING PERFORMANCE EVALUATED. THE SAMPLES DID NOT PRODUCE ANY INSTRUMENT ERRORS ON THE ROCHE COBAS PLATFORM. ALL TUBES PERFORMED AS EXPECTED. THIS COMPLAINT IS NOT CONFIRMED WITH RESPECT TO ERRONEOUS RESULTS-LOW POTASSIUM. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT HAS BEEN CONFIRMED FOR UNDERFILL BASED ON THE PHOTOS PROVIDED. ERRONEOUS RESULTS COULD NOT BE CONFIRMED BASED ON THE TESTING PERFORMED. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD TUBE PMS PLH 13X100 3.5 PLBL LIM CE THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WE NOTICE THAT SOME BARRICOR TUBES ARE NOT FILLED PROPERLY. THE CURRENT BATCH OF BARRICOR TUBES ARE 1229003 EXP 31/12/22 , 2192112 EXP 30/11/23 , 1131899 EXP 30/09/22 , 1256747 EXP 2023."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD TUBE PMS PLH 13X100 3.5 PLBL LIM CE THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD AND ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WE NOTICE THAT SOME BARRICOR TUBES ARE NOT FILLED PROPERLY. THE CURRENT BATCH OF BARRICOR TUBES ARE 1229003 EXP 31/12/22 , 2192112 EXP 30/11/23 , 1131899 EXP 30/09/22 , 1256747 EXP 2023." ADDITIONAL INFO FROM TASK RECEIVED 15DEC2022: 12/11/22: TELEPHONE CALL FROM AN EMERGENCY DOCTOR WITH UNEXPLAINED HYPOKALEMIA AND ADDS THAT OTHER COLLEAGUES HAVE BEEN EXPERIENCING UNWARRANTED UNJUSTIFIED HYPOKALEMIA FOR SOME TIME. WE COMPARED K+ ON COBAS PRO (BARRICOR) OF THE PATIENTS OF 10/11 AND 12/11 WITH THEIR K+ ON BLOOD GAS SYRINGE, THE CORRELATION COEFFICIENT IS 0.91. WE OBSERVE SOME DIFFERENCES BETWEEN THE TWO AUTOMATS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1729722 BD TUBE PMS PLH 13X100 3.5 PLBL LIM CE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown