BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CD138 PE

    MDR report key: 10662624 · Received October 12, 2020

    Report

    Report Number
    2647876-2020-00002
    Event Type
    Malfunction
    Date Received
    October 12, 2020
    Date of Event
    September 8, 2020
    Report Date
    November 13, 2020
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MVU
    UDI-DI
    00382903472062
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY PRODUCT 347206 (CD138 PE, CLONE MI15, ASR) LOT 9350474 MANUFACTURED FROM SUBASSEMBLY 91-0493 BATCH 9304853, WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. THE REVIEW OF THE MANUFACTURING BATCH HISTORY RECORD (BHR) OR RELEASE RECORDS INDICATES PRODUCT PERFORM AS INTENDED PER BD SPECIFICATIONS. RETAIN SAMPLE OF PRODUCT 347206 (CD138 PE, CLONE MI15, ASR) LOT 9350474 WAS EVALUATED UNDER SUBASSEMBLY 91-0493 BATCH 9304853 BY FLOW CYTOMETRY SPECIAL INSTRUCTION TESTING. MULTIPLE MYELOMA CELL LINE RPMI 8226 WAS USED AS TARGET FOR CD138 STAINING, GIVEN ITS KNOWN POSITIVE EXPRESSION OF THIS MARKER (MATSUI ET AL, 2004). ROOT CAUSE IS NOT DETERMINED. CUSTOMER REPORTED THAT PRODUCT 347206 (CD138 PE, CLONE MI15, ASR) LOT 9350474 IS HAVING A PERFORMANCE ISSUE OF DIM STAINING. BD SPECIFICATIONS FOR THIS CD138 PE PRODUCT LOT-TO-LOT FLUORESCENCE VARIABILITY AGAINST A REFERENCE LOT IS -50% TO +100%. EVIDENCE DEMONSTRATES MANUFACTURING PROCESS WAS PERFORMED ACCORDING TO REQUIREMENTS AND PRODUCT MET APPLICABLE SPECIFICATIONS WITHOUT DISCREPANCY. ADDITIONALLY, TESTING BY FLOW CYTOMETRY DID NOT CONFIRMED A FUNCTIONAL PERFORMANCE OF THIS PRODUCT. BASED ON THIS INVESTIGATION, THE CLAIM IS NOT CONFIRMED, AND NO FURTHER ACTIONS ARE DEEMED NECESSARY AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER USE WITH A BD CD138 PE ON 4 PATIENT SAMPLES THE REAGENT DID NOT RELIABLY STAIN CD138 CELLS. RESULTS WERE NOT REPORTED AND THERE WAS NO IMPACT TO PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS REAGENT DOES NOT RELIABLY STAIN CD138+ CELLS WHICH WERE CONFIRMED POSITIVE BY IHC AND BY SUBSEQUENT TESTING WITH CLONE DL-101. THEY HAD BEEN TROUBLESHOOTING DIM STAINING WITH THIS REAGENT, AWARE THAT CD138 EXPRESSION CAN BE VARIABLE. NO ADVERSE PATIENT EVENTS ARE REPORTED. IHC WAS ALSO USED TO CONFIRM POSITIVITY AS AN ALTERNATIVE METHOD. THE LAB HAS BEEN VALIDATING A DIFFERENT CLONE TO REPLACE THIS PRODUCT.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER USE WITH A BD CD138 PE ON 4 PATIENT SAMPLES THE REAGENT DID NOT RELIABLY STAIN CD138 CELLS. RESULTS WERE NOT REPORTED AND THERE WAS NO IMPACT TO PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS REAGENT DOES NOT RELIABLY STAIN CD138+ CELLS WHICH WERE CONFIRMED POSITIVE BY IHC AND BY SUBSEQUENT TESTING WITH CLONE DL-101. THEY HAD BEEN TROUBLESHOOTING DIM STAINING WITH THIS REAGENT, AWARE THAT CD138 EXPRESSION CAN BE VARIABLE. NO ADVERSE PATIENT EVENTS ARE REPORTED. IHC WAS ALSO USED TO CONFIRM POSITIVITY AS AN ALTERNATIVE METHOD.. THE LAB HAS BEEN VALIDATING A DIFFERENT CLONE TO REPLACE THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1131825 BD CD138 PE REAGENTS, SPECIFIC, ANALYTE MVU BECTON DICKINSON CARIBE LTD. 347206 9350474 00382903472062

    Patients

    Seq Age Sex Outcome Treatment
    1 Other