BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BN PROSPEC SYSTEM

    MDR report key: 12333306 · Received August 17, 2021

    Report

    Report Number
    9610806-2021-00055
    Event Type
    Malfunction
    Date Received
    August 17, 2021
    Date of Event
    July 14, 2021
    Report Date
    August 16, 2021
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    JZW
    UDI-DI
    00630414002736
    PMA / PMN Number
    K001647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC). ONE QUALITY CONTROL (QC) RESULT ON (B)(6) 2021 RECOVERED HIGH AND OUT OF RANGE. ADDITIONAL QC ALL RECOVERED IN RANGE, AND THE CALIBRATION CURVES FOR THE TWO REAGENT LOTS DID NOT SHOW ANY ABNORMALITIES. THE SAMPLES WERE CENTRIFUGED CORRECTLY. NO SYSTEM ABNORMALITIES WERE IDENTIFIED. DISCORDANT RESULTS WERE OBTAINED USING BOTH THE POLYPROPYLENE AND POLYSTYRENE SAMPLE TUBES. THERE ARE NO SPECIFICATIONS OR STATEMENTS IN THE ALBUMIN'S INSTRUCTIONS FOR USE NOR IN THE BN PROSPEC SYSTEM INSTRUCTION MANUAL REGARDING THE USE OF POLYSTYRENE TUBES OR POLYPROPYLENE TUBES. THE CAUSE OF THE EVENT IS UNKNOWN. THE SYSTEM IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED. MDRS 9610806-2021-00056 AND 9610806-2021-00057 WERE FILED FOR DISCORDANT RESULTS OBTAINED ON (B)(6) 2021 AND (B)(6) 2021, RESPECTIVELY.

    Description of Event or Problem · 1

    THREE DISCORDANT, FALSELY ELEVATED ALBUMIN RESULTS WERE OBTAINED ON A PATIENT CEREBROSPINAL FLUID (CSF) SAMPLE RUN IN A POLYPROPYLENE TUBE ON A BN PROSPEC SYSTEM USING N ANTISERUM TO ALBUMIN REAGENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED FOR ALBUMIN CSF IN A POLYSTYRENE TUBE ON THE SAME SYSTEM WITH THE SAME REAGENT, RECOVERING LOWER. THE FOLLOWING DAY, THE SAME SAMPLE WAS REPEATED FOR ALBUMIN CSF IN A POLYPROPYLENE TUBE ON THE SAME BN PROSPEC SYSTEM USING A NEW LOT OF N ANTISERUM TO ALBUMIN REAGENT, RECOVERING FALSELY LOW. THE SAMPLE WAS THEN REPEATED TWO ADDITIONAL TIMES FOR ALBUMIN CSF IN A POLYSTYRENE TUBE ON THE SAME SYSTEM WITH THE SAME REAGENT, RECOVERING HIGHER. THE RESULTS OBTAINED IN THE POLYSTYRENE TUBE WERE CONSIDERED CORRECT. TWO DISCORDANT, FALSELY LOW ALBUMIN RESULTS AND ONE DISCORDANT, FALSELY ELEVATED ALBUMIN RESULT WERE OBTAINED ON A SECOND PATIENT CSF SAMPLE RUN IN A POLYPROPYLENE TUBE ON A BN PROSPEC SYSTEM USING N ANTISERUM TO ALBUMIN REAGENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED THREE TIMES FOR ALBUMIN CSF IN A POLYSTYRENE TUBE ON THE SAME SYSTEM WITH THE SAME REAGENT, ONCE RECOVERING FALSELY HIGH AND TWICE RECOVERING ACCEPTABLY. THE FOLLOWING DAY, THE SAME SAMPLE WAS REPEATED FOR ALBUMIN CSF IN A POLYPROPYLENE TUBE ON THE SAME BN PROSPEC SYSTEM USING A NEW LOT OF N ANTISERUM TO ALBUMIN REAGENT, RECOVERING FALSELY LOW. THE SAMPLE WAS THEN REPEATED TWO ADDITIONAL TIMES FOR ALBUMIN CSF IN A POLYSTYRENE TUBE ON THE SAME SYSTEM WITH THE SAME REAGENT, RECOVERING HIGHER. THE LOWER ALBUMIN RESULTS OBTAINED IN THE POLYSTYRENE TUBE WERE CONSIDERED CORRECT. A THIRD PATIENT CSF SAMPLE WAS RUN TWO TIMES FOR ALBUMIN IN A POLYPROPYLENE TUBE ON A BN PROSPEC SYSTEM USING N ANTISERUM TO ALBUMIN REAGENT. THE FOLLOWING DAY, THE SAME SAMPLE WAS REPEATED FOR ALBUMIN CSF IN A POLYPROPYLENE TUBE ON THE SAME BN PROSPEC SYSTEM USING A NEW LOT OF N ANTISERUM TO ALBUMIN REAGENT, RECOVERING HIGHER. THE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). IT IS UNKNOWN WHAT THE CORRECT ALBUMIN RESULT WAS FOR THIS PATIENT. FOUR DISCORDANT, FALSELY ELEVATED ALBUMIN RESULTS WERE OBTAINED ON A FOURTH PATIENT CEREBROSPINAL FLUID (CSF) SAMPLE RUN IN A POLYPROPYLENE TUBE ON A BN PROSPEC SYSTEM USING N ANTISERUM TO ALBUMIN REAGENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED FOUR TIMES FOR ALBUMIN CSF IN A POLYSTYRENE TUBE ON THE SAME SYSTEM WITH THE SAME REAGENT, RECOVERING LOWER. THE RESULTS OBTAINED IN THE POLYSTYRENE TUBE WERE CONSIDERED CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ALBUMIN CSF RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1229964 BN PROSPEC SYSTEM BN PROSPEC SYSTEM JZW SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH BN PROSPEC SYSTEM 00630414002736

    Patients

    Seq Age Sex Outcome Treatment
    1