BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD10 (HI10A) APC

    MDR report key: 19047377 · Received April 4, 2024

    Report

    Report Number
    2647876-2024-00062
    Event Type
    Malfunction
    Date Received
    April 4, 2024
    Date of Event
    March 14, 2024
    Report Date
    August 26, 2024
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MVU
    UDI-DI
    00382903409228
    PMA / PMN Number
    BK230835
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL G5. PMA/510K: , K170974, K201814. H.3. 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 FIELD HAS BEEN UPDATED WITH CORRECTED INFORMATION: D.4. UNIQUE IDENTIFIER (UDI) # : (B)(4). H.4. DEVICE MANUFACTURE DATE: 28-MAR-2023. H.6: BASED ON THE INVESTIGATION RESULTS, THE REPORTED PERFORMANCE ISSUE WAS NOT CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: BATCH HISTORY RECORD (BHR) REVIEW AND LATER MATERIAL USAGE DATA AS A REFERENCE BATCH SHOWING ACCEPTABLE PERFORMANCE. CUSTOMER RESPONSE TO FOLLOW-UP QUESTIONS REVEALED THE REPORTED PROBLEM WAS SOLVED BY RE-INSTALLING THE FACSUITE SOFTWARE. POTENTIAL CAUSE FOR CUSTOMER REPORTED COMPLAINT WAS NOT DETERMINED. THE CUSTOMER STATED THAT AFTER REINSTALLING THE FACSUITE SOFTWARE THEY HAVE NOT SEEN THIS ISSUE WITH CD10 OR ANY OTHER ANTIBODIES AT THIS TIME. THE CUSTOMER ALSO RECEIVED A FREE OF CHARGE ORDER. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING CD10 (HI10A) APC ERRONEOUS RESULTS WERE OBTAINED. ERRONEOUS RESULTS WERE REPORTED, HOWEVER, THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FALSE POSITIVE STAINING OF CD10 APC (340922_3087869) ON B CELLS BY SOFTWARE HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS ERRONEOUS REPORTING OF CD10+ FOLLICULAR LYMPHOMA ON A PATIENT SAMPLE THAT IHC IDENTIFIED AS CD10- MANTLE CELL LYMPHOMA. CLINICAL FAS OPTIMIZED SETTINGS FOR V450 AND ADDED SOME LABEL SPECIFIC SPILLOVER CONTROLS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING CD10 (HI10A) APC ERRONEOUS RESULTS WERE OBTAINED. ERRONEOUS RESULTS WERE REPORTED, HOWEVER, THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FALSE POSITIVE STAINING OF CD10 APC (340922_3087869) ON B CELLS BY SOFTWARE HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS ERRONEOUS REPORTING OF CD10+ FOLLICULAR LYMPHOMA ON A PATIENT SAMPLE THAT IHC IDENTIFIED AS CD10- MANTLE CELL LYMPHOMA. CLINICAL FAS OPTIMIZED SETTINGS FOR V450 AND ADDED SOME LABEL SPECIFIC SPILLOVER CONTROLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2374008 CD10 (HI10A) APC REAGENTS, SPECIFIC, ANALYTE MVU BECTON DICKINSON CARIBE LTD. 3087869 00382903409228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown