BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CHEMISTRY XPT

    MDR report key: 8764163 · Received July 5, 2019

    Report

    Report Number
    2432235-2019-00229
    Event Type
    Malfunction
    Date Received
    July 5, 2019
    Date of Event
    June 17, 2019
    Report Date
    August 27, 2019
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    UDI-DI
    00630414595467
    PMA / PMN Number
    K990346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 2432235-2019-00229 ON 05-JULY-2019. CORRECTED INFORMATION (07-JULY-2019): THE INITIAL MDR REPORT INDICATES: "THE CAUSE OF THE DISCORDANT, FALSELY LOW CREATININE CONCENTRATED (CRE_2C) RESULT IS UNKNOWN". THE INITIAL MDR ALSO INDICATES: "REAGENT PROBES AND PUMPS DELIVER REAGENT TO REACTION CUVETTES AND SIEMENS DETERMINED THAT THE RP1 TO CUVETTE MISALIGNMENT AND LEAKS CREATE INCONSISTENT VOLUME DELIVERY, WHICH CONTRIBUTED TO THE DISCORDANT, FALSELY LOW CREATININE CONCENTRATED (CRE_2C) RESULT." SIEMENS IS CLARIFYING THAT RP1 TO CUVETTE MISALIGNMENT AND LEAKS CREATE INCONSISTENT VOLUME DELIVERY, WHICH CONTRIBUTED TO THE DISCORDANT, FALSELY LOW CREATININE CONCENTRATED (CRE_2C) RESULT. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED INITIAL MDR 2432235-2019-00229 ON 05-JUL-2019 AND THE FIRST SUPPLEMENTAL MDR ON 09-JUL-2019. ADDITIONAL INFORMATION (05-AUG-2019): THE CUSTOMER CONFIRMED THAT THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). SECTION B5 WAS UPDATED TO REFLECT THE ADDITIONAL INFORMATION. CORRECTED INFORMATION (05-AUG-2019): THE INITIAL MDR INDICATED THAT THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT AND AN ALTERNATE ADVIA CHEMISTRY INSTRUMENT. THE CUSTOMER CLARIFIED THAT THE SAMPLE WAS REPEATED ON THE ALTERNATE ADVIA CHEMISTRY INSTRUMENT TWICE, AND NOT REPEATED ON THE INITIAL INSTRUMENT. SECTION B5 AND SECTION B6 WERE UPDATED TO REFLECT THE CORRECTED INFORMATION. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 0

    A DISCORDANT, FALSELY LOW CREATININE CONCENTRATED (CRE_2C) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA CHEMISTRY XPT INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED TWICE ON AN ALTERNATE ADVIA CHEMISTRY INSTRUMENT; THE REPEAT RESULTS WERE HIGHER THAN THE DISCORDANT RESULT. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW CRE_2C RESULT.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER. THE CUSTOMER CHECKED THE LAMP AND RAN A PRECISION TEST, WHICH RECOVERED ACCEPTABLY. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE CSE INSPECTED THE INSTRUMENT AND CHECKED THE PROBES AND MIXERS ALIGNMENTS, VACUUM PUMP, AND ASPIRATION OF PROBES ON THE REACTION TRAY WASH UNIT (WUD) AND DILUTION TRAY WASH UNIT (DWUD). THE CSE OBSERVED THE FOLLOWING: REAGENT PROBE 1 (RP1) TO CUVETTE MISALIGNMENT, KINKED IN THE TUBING OF ASPIRATION PROBE 1 ON DWUD, AND REAGENT SPLATTERS ON THE REAGENT COMPARTMENT 2 LID. THE CSE REPLACED THE REAGENT DISPENSING PUMP 2 (RP2) SEALS AND PERFORMED ALIGNMENTS ON THE INSTRUMENT. REAGENT PROBES AND PUMPS DELIVER REAGENT TO REACTION CUVETTES AND SIEMENS DETERMINED THAT THE RP1 TO CUVETTE MISALIGNMENT AND LEAKS CREATE INCONSISTENT VOLUME DELIVERY, WHICH CONTRIBUTED TO THE DISCORDANT, FALSELY LOW CREATININE CONCENTRATED (CRE_2C) RESULT. THE CSE ALSO TURNED ON THE WATER SUPPLY PUMP (LWP) TO INSPECT THE SEALS ON THE DILUTION AND SAMPLE PROBES AND FOUND NO ISSUE. THEN, THE CSE RAN A PRECISION STUDY AND QUALITY CONTROLS (QCS); THE PRECISION STUDY AND QCS RECOVERED ACCEPTABLY. THE CAUSE OF THE DISCORDANT, FALSELY LOW CREATININE CONCENTRATED (CRE_2C) RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY LOW CREATININE CONCENTRATED (CRE_2C) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA CHEMISTRY XPT INSTRUMENT. THE DISCORDANT RESULT MAY HAVE BEEN REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT AND ON AN ALTERNATE ADVIA CHEMISTRY INSTRUMENT; THE REPEAT RESULTS WERE HIGHER THAN THE DISCORDANT RESULT. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW CRE_2C RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556733 ADVIA CHEMISTRY XPT ADVIA CHEMISTRY XPT JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CHEMISTRY XPT 00630414595467

    Patients

    Seq Age Sex Outcome Treatment
    1