BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-SED®ESR BI-LEVEL CONTROL

    MDR report key: 7698787 · Received July 18, 2018

    Report

    Report Number
    2243072-2018-00477
    Event Type
    Malfunction
    Date Received
    July 18, 2018
    Date of Event
    June 25, 2018
    Report Date
    September 5, 2018
    Manufacturer
    BECTON DICKINSON
    Product Code
    GKB
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: B.2. EVENT ATTRIBUTED TO: OTHER. D.8. DEVICE SINGLE USE?: NO. H.3. DEVICE RETURNED TO MANUFACTURE: NO. H.6. INVESTIGATION: INVESTIGATION SUMMARY: THE INVESTIGATION DETERMINED THE BARCODE NUMBER (AND THEREFORE THE BARCODE ITSELF) FOR THE ACCU-SED® NORMAL CONTROL (LEVEL 1) OF LOT NUMBERS #1823500, #1823500-1, #1823500-2 AND #1823500-3 WAS INCORRECT FOR THE MONITOR AND BD SEDI INSTRUMENTS. THIS COULD RESULT IN PROBLEMS TO ENTER THE DATA FOR THIS LEVEL FOR THESE INSTRUMENT TYPES THAT ARE EQUIPPED WITH A QC PROGRAM. BD HAD INITIATED FURTHER INVESTIGATION RELATING TO THIS ISSUE THROUGH A CAPA AND AS A RESULT, CORRECTIVE ACTIONS WERE IMPLEMENTED. A REVISED IFU (REV. C) CONTAINING THE CORRECT BARCODES WAS COMMUNICATED TO ALL BD CUSTOMERS ON (B)(6) 2018. INVESTIGATION CONCLUSION: THE CUSTOMER'S INDICATED FAILURE MODE FOR THE BARCODE ERROR WAS OBSERVED BY BD. FURTHER INVESTIGATION ACTIVITIES WERE CONDUCTED THROUGH A CAPA AND THE MOST LIKELY ROOT CAUSE WAS IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS AND PROCEDURES WERE IMPLEMENTED TO MITIGATE FURTHER OCCURRENCES. ROOT CAUSE DESCRIPTION: THE ROOT CAUSE WAS ATTRIBUTED TO A MANUFACTURING INCIDENT. BD HAD INITIATED FURTHER INVESTIGATION THROUGH A CAPA. THE CAPA HAD IDENTIFIED THE MOST LIKELY ROOT CAUSES AND CORRECTIVE ACTIONS WERE IMPLEMENTED. RATIONALE: BASED ON AN ASSESSMENT OF SEVERITY AND FREQUENCY, IT WAS DETERMINED THAT A CAPA WAS REQUIRED IN ORDER TO DETERMINE THE ROOT CAUSE ASSOCIATED WITH THIS ISSUE. THE INVESTIGATION IDENTIFIED ROOT CAUSE(S) FOR THIS ISSUE AND CORRECTIVE ACTIONS WERE IMPLEMENTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ACCU-SED®ESR BI-LEVEL CONTROL HAD A BARCODE DEFECT IN WHICH THE INSTRUMENT WOULD NOT RECOGNIZE THE BARCODE SCANNED IN NOR MANUALLY ENTERED. NO REPORT OF INJURY OR MEDICAL INTERVENTION. NO REPORT OF BLOOD EXPOSURE TO MUCOUS MEMBRANE.

    Additional Manufacturer Narrative · 1

    (B)(6). THE REPORTED LOT# 1823500 WAS NOT FOUND FOR THE REPORTED CATALOG NUMBER. 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 ACCU-SED®ESR BI-LEVEL CONTROL HAD A BARCODE DEFECT IN WHICH THE INSTRUMENT WOULD NOT RECOGNIZE THE BARCODE SCANNED IN NOR MANUALLY ENTERED. NO REPORT OF INJURY OR MEDICAL INTERVENTION. NO REPORT OF BLOOD EXPOSURE TO MUCOUS MEMBRANE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541989 ACCU-SED®ESR BI-LEVEL CONTROL ESR INSTRUMENT GKB BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other