BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® URINE COLLECTION CUP

    MDR report key: 7573963 · Received June 6, 2018

    Report

    Report Number
    9617032-2018-00220
    Event Type
    Malfunction
    Date Received
    June 6, 2018
    Date of Event
    May 17, 2018
    Report Date
    June 22, 2018
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JTW
    PMA / PMN Number
    K790366
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD VACUTAINER® URINE COLLECTION CUPS ARE SINGLE USE STERILE CONTAINERS INTENDED FOR THE COLLECTION AND CONTAINMENT OF URINE. THEY ARE EQUIPPED WITH AN INTEGRATED TRANSFER DEVICE TO ENABLE TRANSFER OF URINE FROM THE COLLECTION CUP INTO EVACUATED URINE TUBES. BD VACUTAINER® URINALYSIS NO ADDITIVE TUBES AND THE BD VACUTAINER® URINALYSIS PRESERVATIVE TUBE (UAP) ARE USED FOR AUTOMATED DIPSTICK CHEMISTRY ANALYSIS AND TO OBTAIN SEDIMENT FOR EXAMINATION. ELEVATED RBC (RED BLOOD CELL) COUNTS HAVE BEEN REPORTED TO BD BY SYSMEX AMERICA, INC., WHO HAVE STATED THAT THEY HAVE RECEIVED COMPLAINTS FROM THEIR CUSTOMERS WHO HAVE USED THE BD VACUTAINER® URINALYSIS NO ADDITIVE TUBES, FILLED USING BD VACUTAINER® URINE CUPS AND ANALYZED WITH THE SYSMEX UF-1000I¿ AUTOMATED URINE PARTICLE ANALYZER. THE BD VACUTAINER® URINALYSIS NO ADDITIVE TUBES ARE NOT LABELED SPECIFICALLY FOR USE WITH THE SYSMEX UF-1000I¿ AUTOMATED URINE PARTICLE ANALYZER. THE SYSMEX UF-1000I¿ URINE SEDIMENT ANALYZER IS INTENDED FOR QUANTITATIVE AND QUALITATIVE ANALYSIS OF URINE FROM PATIENT POPULATIONS IN THE CLINICAL SETTING. THE INSTRUMENT UTILIZES FLUORESCENT FLOW CYTOMETRY TO CLASSIFY AND QUANTIFY THE CELLULAR ELEMENTS OF URINARY SEDIMENT. THE UF-1000I¿ PROVIDES QUALITATIVE RESULTS FOR YLC (YEAST-LIKE CELLS), XTAL (CRYSTALS), PATHOLOGIC CASTS, SPERM AND SRC (SMALL ROUND CELLS). THE UF-1000I¿ CLASSIFIES RBC BASED ON SIZE AND AMOUNT OF FLUORESCENCE. THE SIZE AND FLUORESCENCE READINGS CREATE A WAVEFORM PATTERN, WHICH IS UNIQUE FOR EACH PARTICLE TYPE AND ALLOWS THE UF TO DISTINGUISH RBC FROM CRYSTALS, YEAST, AND OTHER CELLS. SAMPLES OR PHOTOS OF DEVICES THAT ARE ALLEGED TO HAVE RESULTED IN THESE COMPLAINTS HAVE NOT BEEN RECEIVED FROM THE CUSTOMER FACILITY FOR EVALUATION BY BD. SYSMEX HAS NOT PROVIDED SPECIFIC LOT NUMBER INFORMATION ASSOCIATED WITH THESE ALLEGED COMPLAINTS. BD HAS CONDUCTED TWO FOLLOW-UP CONTACT ATTEMPTS TO SYSMEX FOR FURTHER DETAIL REGARDING SPECIFIC COMPLAINTS AND HAS NOT RECEIVED FURTHER COMPLAINT INFORMATION. THEREFORE, INVESTIGATION HAS BEEN LIMITED AND REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. BD CONDUCTED FURTHER INVESTIGATION TO COMPARE RBC COUNTS IN URINE SAMPLES USING VARIOUS SAMPLE COLLECTION METHODS WITH ANALYSIS CONDUCTED ON THE SYSMEX UF-1000I¿. THE OBJECTIVE OF THIS STUDY WAS TO COMPARE THE RESULTS OF THE RBC COUNTS OBTAINED USING THE SYSMEX UF-1000I¿ FROM SAMPLES COLLECTED INTO THREE BD URINALYSIS NO ADDITIVE TUBE AND THREE BD URINALYSIS PRESERVATIVE TUBES: ONE EACH FILLED USING THE URINE CUP, ONE EACH FILLED USING THE TRANSFER STRAW, AND ONE EACH FILLED BY MANUALLY POURING INTO THE TUBE. THE INVESTIGATION CONCLUDED THE FOLLOWING: RBC COUNTS WERE HIGHER WITH SAMPLES COLLECTED INTO BD UAP TUBES BY MEANS OF THE URINE CUP TRANSFER SYSTEM. OUT OF 60 SUBJECTS, WHICH WERE HEALTHY VOLUNTEERS, 11 SAMPLES FILLED USING THE URINE CUP SHOWED INCREASED RBC COUNTS ABOVE SYSMEX¿S RECOMMENDED SPECIFICATIONS (23 RBCS / L). TWO OUT OF THE 11 SAMPLES WITH ABNORMAL RBC COUNTS WOULD HAVE THE POTENTIAL TO BE ¿FALSE POSITIVES,¿ WHICH CAN LEAD TO A REPEAT TEST OR ADDITIONAL DIAGNOSTIC TESTING. THERE IS NO SIGNIFICANT DIFFERENCE OBSERVED IN RBC COUNTS WITH SAMPLES COLLECTED INTO THE UAP TUBE. BD VACUTAINER® URINALYSIS NO ADDITIVE TUBES CONSISTENTLY SHOW LOWER RBC COUNTS ON 2ND DRAWN TUBE VERSUS THE 1ST TUBE, WHICH ARE BOTH WITHIN SYSMEX¿S RECOMMENDED SPECIFICATIONS (<23 RBCS /L). THE DATA INDICATES THAT THERE IS AN INCREASE IN ELEVATED RBC COUNTS FROM THE BD VACUTAINER® URINALYSIS NO ADDITIVE TUBES FILLED USING THE CUP. STANDARD MEDICAL TREATMENT FOR URINE ANALYSIS TESTING IS TO FOLLOW UP ANY ABNORMALITY ON THE URINE CHEMISTRY WITH MICROSCOPIC CONFIRMATION OF THE SAMPLE. THERE ARE ACCREDITATION REQUIREMENTS FROM COLLEGE OF AMERICAN PATHOLOGISTS (CAP) AND CLINICAL LABORATORY STANDARDS INSTITUTE (CLSI) GUIDELINES THAT RECOMMEND INSTITUTIONS DEVELOP POLICIES AND PROCEDURES TO ADDRESS AND MANAGE HOW TESTING AND CONFIRMATION OF RESULTS ARE HANDLED, THEREBY MITIGATING THE REPORTING OF ERRONEOUS RESULTS. IF ERRONEOUS RBC¿S ARE REPORTED ON THE URINE ANALYSIS, REPEAT URINALYSIS TESTING SHOULD BE PERFORMED AND RESULTS CORRELATED WITH THE PATIENT¿S CLINICAL CONDITION [1]. THEREFORE, THE HEALTH RISK IS CONSIDERED IMPROBABLE, DUE TO THE NATURE OF THE SITUATION, ACCORDING TO OUR HEALTH HAZARD EVALUATION CONDUCTED BY MEDICAL AFFAIRS. AS PART OF ITS ONGOING INVESTIGATION OF THIS MATTER, BD IS CONDUCTING A DESIGN OF EXPERIMENTS (DOE) TO DETERMINE THE POTENTIAL CAUSES OF THE ELEVATED RBC COUNTS WHEN BD VACUTAINER® URINE TUBES ARE USED ON THE UF-1000I SYSMEX ANALYZER. RESULTS AND POTENTIAL ROOT CAUSES WILL BE DOCUMENTED AS PART OF A CAPA. INVESTIGATION CONCLUSION: FURTHER INVESTIGATION HAS BEEN INITIATED THROUGH A CAPA. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES ARE IDENTIFIED. ROOT CAUSE DESCRIPTION: BD HAS INITIATED FURTHER INVESTIGATION THROUGH A CAPA TO IDENTIFY THE POTENTIAL ROOT CAUSE(S). CAPA (B)(4). RATIONALE: BASED ON AN ASSESSMENT OF SEVERITY AND FREQUENCY, IT WAS DETERMINED THAT A CAPA IS REQUIRED AT THIS TIME IN ORDER TO DETERMINE THE ROOT CAUSE ASSOCIATED WITH THIS ISSUE AND IMPLEMENT CORRECTIVE ACTIONS. THE INVESTIGATION IS CURRENTLY ON-GOING AND FURTHER IMPROVEMENTS WILL BE MADE AS THE POTENTIAL ROOT CAUSE(S) ARE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ERRONEOUS RESULTS WERE RECEIVED WHEN USING THE BD VACUTAINER® URINE COLLECTION CUP. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417889 BD VACUTAINER® URINE COLLECTION CUP URINE COLLECTION SET JTW BECTON, DICKINSON AND COMPANY (BD) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other