BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CD81 APC-H7 (JS-81) ASR

    MDR report key: 10271029 · Received July 14, 2020

    Report

    Report Number
    2916837-2020-00058
    Event Type
    Malfunction
    Date Received
    July 14, 2020
    Date of Event
    June 24, 2020
    Report Date
    September 14, 2020
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    MVU
    UDI-DI
    00382906561541
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ¿ MANUFACTURING DEFECT TREND: FROM 07/20/2020 BACK TO 06/20/2019, NO QN WAS GENERATED IN SAP FOR THE FOLLOWING MATERIALS: 656154 AND 91-0885. ¿ COMPLAINT TREND: ASIDE FOR THIS PIR#1644280, THERE IS NO OTHER PIR COMPLAINT REPORTED FOR CATALOG# 656154 FROM DATE 01JUL2020 BACK TO 01JUL2019. ¿ BATCH HISTORY RECORD REVIEW: REVIEWED PRODUCTION BATCH RECORDS FOR MATERIAL 656154-9060975 AND THE IN-PROCESS MATERIAL 91-0885-9022655. BATCH RECORD REVIEW OF 656154-9060975 SHOWED THAT THE PRODUCT COMPLIES WITH ALL THE QC RELEASED CRITERIA. BATCH RECORD REVIEW OF 91-0885-9022655 SHOWED THAT PRODUCT PASSED ALL THE QC SPECIFICATIONS AS DESIGNED. ¿ RESULT OF RETAIN SAMPLE TESTING: RETAIN SAMPLE OF 91-0885-9022655 SAMPLE WAS USED TO STAIN WITH NORMAL PERIPHERAL BLOOD. THE REAGENT COCKTAIL ALSO CONTAIN CD45 FITC AND CD3 PE TO AID IN THE GATING OF THE BLOOD CELL POPULATIONS. STAINING RESULT SHOWED THAT THE FOLLOWING POPULATIONS: LYMPHOCYTES, MONOCYTES AND EOSINOPHILS WERE POSITIVE FOR CD81 APCH7. NEUTROPHILS SHOWED AS A NEGATIVE POPULATION. THE PRODUCT FUNCTIONED AS INTENDED. ¿ RESULT OF RETURNED SAMPLE EVALUATION: A TASK WAS CREATED 1660982, TO REQUEST FOR A DOT PLOT SAMPLE FROM THE CUSTOMER. THREE ATTEMPTS TO CONTACT THE CUSTOMER BY THE CUSTOMER COMPLAINT SPECIALIST. AS OF THIS WRITING, JULY 20, NO RESPONSE FROM THE CUSTOMER WAS RECEIVED. AS PER COMMUNICATION WITH CUSTOMER COMPLAINT SPECIALIST, THE REAGENT WAS USED AFTER THE ASSIGNED EXPIRATION DATE. ¿ INVESTIGATION RESULT / ANALYSIS: RETAIN SAMPLE OF 91-0885-9022655 SAMPLE WAS USED TO STAIN WITH NORMAL PERIPHERAL BLOOD. THE REAGENT COCKTAIL ALSO CONTAIN CD45 FITC AND CD3 PE TO AID IN THE GATING OF THE BLOOD CELL POPULATIONS. STAINING RESULT SHOWED THAT THE FOLLOWING POPULATIONS: LYMPHOCYTES, MONOCYTES AND EOSINOPHILS WERE POSITIVE FOR CD81 APCH7. NEUTROPHILS SHOWED AS A NEGATIVE POPULATION. THE PRODUCT FUNCTIONED AS INTENDED. ¿ RISK ANALYSIS: REVIEWED RISK ANALYSIS DOCUMENT: SAP#100311RA REV06, ENTITLED ANTIBODY AND ANTIBODY CONJUGATES ASR-RUO DOCUMENT HAZARD(S) IDENTIFIED? YES HAZARD #: 3. FUNCTIONAL 3.1.3 FUNCTIONAL HAZARD CAUSE: PRODUCT DEGRADATION BEFORE ASSIGNED EXPIRATION DATE. HARMFUL EFFECTS: ABERRANT RESULT PROBABILITY: 2 SEVERITY: 3 RISK INDEX: 6 INITIAL RISK EVALUATION: UNACCEPTABLE RISK CONTROL: REAL TIME STABILITY STUDY IMPLEMENTATION VERIFICATION: QS STABILITY STUDY EFMC-15-37P EFMC-16-39P CLINICAL TRIAL ACCURACY STUDY PROTOCOL (CAS-EFMACC4 MITIGATION(S) SUFFICIENT: YES ¿ ATTACHED PICS/DOCS FROM INVESTIGATION: PIR# 164480 CD81 APCH7 ATTACHMENT. ¿ ROOT CAUSE: NO ROOT CAUSE IDENTIFIED. PRODUCT FUNCTIONED AS INTENDED. ¿ INVESTIGATION CONCLUSION THE COMPLAINT IS UNCONFIRMED AS A MANUFACTURING DEFECT. THE PRODUCT FUNCTIONED AS INTENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE THEY WERE LOSING APC CHANNEL RESOLUTION WITH A BD CD81 APC-H7 (JS-81) ASR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER FOUND TANDEM DYE DEGRADATION AFTER USING A PERIOD BEFORE EXPIRY DATE.

    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 DURING USE THEY WERE LOSING APC CHANNEL RESOLUTION WITH A BD CD81 APC-H7 (JS-81) ASR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER FOUND TANDEM DYE DEGRADATION AFTER USING A PERIOD BEFORE EXPIRY DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738001 BD CD81 APC-H7 (JS-81) ASR NA MVU BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 656154 9060975 00382906561541

    Patients

    Seq Age Sex Outcome Treatment
    1 Other