BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIXSPEC¿ CALIBRATOR KIT

    MDR report key: 11959044 · Received June 8, 2021

    Report

    Report Number
    1119779-2021-00956
    Event Type
    Malfunction
    Date Received
    June 8, 2021
    Date of Event
    May 9, 2021
    Report Date
    November 30, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JQX
    UDI-DI
    00382904409111
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY AN INCORRECT READING WAS REPORTED WHEN USING A KIT PHOENIXSPEC CALIBRATOR (P/N 440911, BATCH 1004886). THE CUSTOMER REPORTED THAT THE 0.25 MCF TUBE IN THE KIT WAS READING 0.29 MCF. THE SPECIFICATION FOR THIS TUBE IS 0.24 - 0.28 MCF. THE CUSTOMER ADVISED BD THAT THE TUBE WAS NOT CREATING AN ERROR WHEN CALIBRATING THEIR PHOENIXSPEC NEPHELOMETER, AND NO IMPACT ON SAMPLE PREPARATION WAS REPORTED AS A RESULT OF THIS INCORRECT READING. THE CUSTOMER DISCOVERED THE READING WHEN PERFORMING QC VERIFICATION ON THEIR PHOENIX AP INSTRUMENT. THE CUSTOMER DID NOT ADVISE WHAT THE TUBE WAS READING ON THEIR NEPHELOMETER. BD PROVIDED A REPLACEMENT NEPHELOMETER, BUT THIS DID NOT RESOLVE THE ISSUE WITH THE CALIBRATOR KIT. THE ROOT CAUSE IS UNKNOWN. AS NO CALIBRATION FAILURE WAS REPORTED AND IT IS NOT KNOWN IF THE SOURCE OF THE INCORRECT READING WAS THE PHOENIX AP INSTRUMENT, THIS IS AN UNCONFIRMED FAILURE OF THE CALIBRATOR KIT. IF MORE INFORMATION IS RECEIVED, THIS COMPLAINT MAY BE RE-OPENED. SAMPLES WERE NOT RECEIVED BY QUALITY FOR INVESTIGATION AND THUS, RETURNED MATERIAL INVESTIGATION COULD NOT OCCUR. IF SAMPLES OR FURTHER INFORMATION IS RECEIVED AT A LATER DATE, THE COMPLAINT MAY BE REOPENED. REVIEW OF THE DEVICE HISTORY RECORD CONSISTED OF A REVIEW OF THE INSPECTION AND PACKAGING DOCUMENTATION FOR BATCH 1004886, AS WELL AS THE CERTIFICATE OF CONFORMANCE FOR THIS BATCH OF CALIBRATORS. THE 0.25 MCF CALIBRATOR (P/N 8011860, BATCH 20430049) INSPECTION AND MANUFACTURING INFORMATION WERE REVIEWED. THE MATERIAL WAS RELEASED IN GOOD CONDITION. SERVICE HISTORY REVIEW WAS CONDUCTED BY INVESTIGATING ALL COMPLAINTS RECEIVED BY THIS CUSTOMER LOCATION. NO FURTHER COMPLAINTS WERE IDENTIFIED RELATED TO THE CALIBRATOR KIT. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH THIS COMPLAINT. NO NEW RISKS OR HAZARDS, OR CHANGES TO EXISTING RISKS/HAZARDS, WERE IDENTIFIED AS A RESULT OF THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PHOENIXSPEC¿ CALIBRATOR KIT ATYPICAL GROWTH WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " EVIDENCE OF READING OUT OF RANGE OF NEW PHOENIX SPEC CALIBRATION KIT 0.25 MF STANDARD TUBE. SHOWS HIGHER THAN NORMAL READING (0.29 MF). LOT 1004886 F EXPIRATION 2021-11-06. "

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD PHOENIXSPEC¿ CALIBRATOR KIT ATYPICAL GROWTH WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "EVIDENCE OF READING OUT OF RANGE OF NEW PHOENIX SPEC CALIBRATION KIT 0.25 MF STANDARD TUBE. SHOWS HIGHER THAN NORMAL READING (0.29 MF). LOT 1004886 F, EXPIRATION: 2021-11-06."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853245 BD PHOENIXSPEC¿ CALIBRATOR KIT NEPHELOMETER, FOR CLINICAL USE JQX BECTON, DICKINSON & CO. (SPARKS) 440911 1004886 00382904409111

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown