BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYVA® EMIT

    MDR report key: 9557725 · Received January 7, 2020

    Report

    Report Number
    2517506-2020-00003
    Event Type
    Malfunction
    Date Received
    January 7, 2020
    Date of Event
    November 5, 2019
    Report Date
    February 18, 2020
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    KLR
    UDI-DI
    00842768001390
    PMA / PMN Number
    K832799
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MDR 2517506-2020-00003 WAS FILED 07-JAN-2020 MDR 2517506-2020-00002 WAS FILED 07-JAN-2020 FOR PATIENT TEST RESULTS OBTAINED ON 04-NOV-2019. NEW INFORMATION (24-JAN-2020). COMPLAINT ASSESSMENT: SIEMENS HEADQUARTER SUPPORT CENTER (HSC) AND GLOBAL ASSAY DEVELOPMENT (GAD) HAVE CONCLUDED TESTING OF THE RETURNED PATIENT SAMPLES FROM THE CUSTOMER SITE. TESTING WAS PERFORMED ON BOTH THE BECKMAN AU680 AND THE VIVA E ANALYZERS. BOTH LEVELS OF THE QUALITY CONTROL (QC) WERE PROCESSED IN DUPLICATE ON THE AU680 ANALYZER AND IN TRIPLICATE ON THE VIVA-E ANALYZER. ALL QUALITY CONTROL WAS IN THE EXPECTED RANGE ON BOTH THE AU680 AND THE VIVA-E ANALYZERS. RESULTS ARE SHOWN BELOW: INSTRUMENT: RESULTS WERE PROCESSED IN DUPLICATE. AU680, 6.0/6.2 MEAN =6.1 G/ML. VIVA-E , 6.4/6.6 MEAN = 6.5 G/ML. THIS IS CONSISTENT WITH WHAT THE LABORATORY OBSERVED WHEN THEY REPROCESSED THIS SAMPLE AT THE PHARMACISTS REQUEST ON 08-NOV-2019 WHICH RESULTED AS 5.34 G/ML. SINCE THERE WAS NOT MUCH SAMPLE LEFT GAD PROCESSED THE SECOND SAMPLE WHICH HAD BEEN COLLECTED ON 04-NOV-2019 AT 17:00 ON THE VIVA-E ANALYZER ONLY AND THE RESULTS WERE PROCESSED IN DUPLICATE: 8.3/8.3 MEAN = 8.3 G/ML. THIS IS CONSISTENT WITH THE RESULTS OBTAINED ON 08-NOV-2019 AT WADE MEDICAL LAB: 6.92 G/ML. GAD TESTING DID NOT DUPLICATE WHAT THE CUSTOMER CLAIMED TO OBSERVE WHEN THEY RAN BOTH SAMPLES INITIALLY. IT WAS NOTED THAT THE CUSTOMER HAD TESTED FOR CREATININE ON THE FIRST COLLECTED SAMPLE WHEN TESTING FOR LIDOCAINE AND THE RESULT WAS 0.0 MG/DL, WHICH IS NOT WHAT ONE WOULD EXPECT FROM A PATIENT WITH RENAL FAILURE. HSC PRESENTED REFERENCES FOR NORMAL CREATININE LEVELS IN ADULTS: 0.84 TO 1.21 MG/DL (ADULTS) MAYO CLINIC. 0.9 TO 1.3 MG/DL FOR ADULT MALES UNIVERSITY OF ROCHESTER MEDICAL CENTER. 0.7-1.2 MG/DL FOR ADULT MALES PER MEDICAL NEWS TODAY. TESTING PERFORMED BY SIEMENS TECHNICAL OPERATIONS ON EMIT LIDOCAINE REAGENT LOTS M1 (COMPLAINT LOT) AND M2 (REFERENCE LOT) FROM RETAINS INDICATES THE REAGENTS ARE WORKING AS INTENDED. THE REAGENTS WERE TESTED ON THE SYVA 30R (RELEASE ANALYZER), ELITECH V-TWIN ANALYZER, ELITECH PROE ANALYZER AND BECKMAN AU640 ANALYZER FOR CALIBRATION, QC RECOVERY, AND RATE MODE. ALL CALIBRATIONS, QC RECOVERY AND CURVE SEPARATION MET THE ACCEPTANCE CRITERIA. THERE IS NO APPARENT DIFFERENCE BETWEEN THE TWO LIDOCAINE REAGENT LOTS, AND NO SIGNIFICANT CHANGE COMPARED WITH RELEASE TESTING RESULTS. NO PRODUCT NON CONFORMANCE IS OBSERVED. REAGENT IS WORKING AS INTENDED. ROOT CAUSE CANNOT BE DETERMINED AND IS INCONCLUSIVE. SIEMENS IS UNABLE TO REPRODUCE THE CUSTOMER DESCRIBED EXPERIENCE WITH THIS PATIENT'S SAMPLES. HSC IS NOT ABLE TO RULE OUT AN ISSUE SPECIFIC TO THIS PATIENT'S SAMPLES OR ANY INSTRUMENT ISSUES AT TIME OF TESTING WHEN THE SAMPLE WAS BEING DELIVERED INTO THE CUVETTES BY THE ANALYZER. THE CUSTOMER HAS NOT OBSERVED ANY ISSUES WITH ANY OTHER SAMPLES THAT HAVE BEEN PROCESSED. SECTION H6 HAS BEEN UPDATED TO REFLECT THE HSC INVESTIGATION. MDR 2517506-2020-00002 SUPPLEMENT 1 HAS BEEN FILED FOR THE PATIENT TEST RESULTS OBTAINED ON 04-NOV-2019.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS CUSTOMER CARE CENTER (CCC) TO REPORT THAT A DISCORDANT DEPRESSED SIEMENS EMIT LIDOCAINE RESULT WAS OBTAINED ON A PATIENT SAMPLE WHILE USING A NON-SIEMENS INSTRUMENT. THE CUSTOMER, (B)(6) MEDICAL LABORATORY, STATED THAT PATIENT SAMPLE (B)(6) WAS COLLECTED AT AN ALTERNATE FACILITY, (B)(6) HOSPITAL, AND TRANSFERRED TO (B)(6) MEDICAL LABORATORY FOR TESTING AND REPORTING. IT IS UNKNOWN IF ANY LIDOCAINE TESTING WAS PERFORMED AT (B)(6) HOSPITAL. ON (B)(6) 2019, USER REPORTED ISSUE WITH FALSELY LOW (NEGATIVE) LIDOCAINE RESULTS FOR ONE PATIENT'S SAMPLES TESTED ON A BECKMAN COULTER AU680® ANALYZER, WITH THE SIEMENS SYVA EMIT LIDOCAINE ASSAY, LOT M1. TWO SAMPLES WERE AFFECTED FROM THE SAME PATIENT ON TWO CONSECUTIVE SAMPLES; SAMPLE 1, COLLECTED AT 03:27A ON (B)(6) 2019 AND SAMPLE 2, COLLECTED AT 17:00P ON (B)(6) 2019. INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN. PHARMACIST QUESTIONED THESE RESULTS DAYS LATER ON (B)(6) 2019, AS HIGHER RESULTS WERE TO BE EXPECTED. LABORATORY THEN REPEATED THE ORIGINAL PATIENT SAMPLES AND OBTAINED HIGHER LIDOCAINE VALUES, CORRECTED REPORTS WERE ISSUED. THE PATIENT EXPIRED BEFORE THE RESULTS OF THE 17:00P (B)(6) 2019 SAMPLE WERE REPORTED. SIEMENS IS INVESTIGATING THE EVENT. IT IS NOT KNOWN IF THE DISCREPANT RESULTS WERE DUE TO THE SIEMENS SYVA EMIT LIDOCAINE REAGENT OR THE BECKMAN COULTER AU680® INSTRUMENT OR SOME OTHER REASON. MDR 2517506-2020-00002 WAS FILED FOR PATIENT TEST RESULTS OBTAINED ON (B)(6) 2019.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DISCORDANT DEPRESSED LIDOCAINE RESULT WAS OBTAINED ON A PATIENT SAMPLE PROCESSED (B)(6) 2019 ON A NON-SIEMENS INSTRUMENT USING THE SIEMENS SYVA EMIT LIDOCAINE REAGENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN. THE CUSTOMER STATED THAT THE DISCORDANT INITIAL LIDOCAINE RESULT WAS REPORTED TO THE PHYSICIAN. THE CUSTOMER INFORMED SIEMENS THAT ON A LATER DATE (AND SUBSEQUENT TO THE DEATH OF THE PATIENT) A PHARMACIST QUESTIONED THE DEPRESSED LIDOCAINE RESULT AND THE SAME PATIENT SAMPLE WAS REPROCESSED AT THAT TIME USING THE SAME SIEMENS SYVA EMIT LIDOCAINE REAGENT ON THE SAME NON-SIEMENS SYSTEM. A HIGHER RESULT WAS OBTAINED AND A CORRECTED REPORT WAS ISSUED. THE CUSTOMER STATED THAT THE PATIENT EXPIRED ON (B)(6) 2019. THE EXACT TIME OF THE PATIENT EXPIRATION HAS NOT BEEN PROVIDED. THE CUSTOMER INFORMED SIEMENS THAT THE LABORATORY PATHOLOGIST STATED THAT THE PATHOLOGIST REPORT AT THE HOSPITAL WHERE THE PATIENT EXPIRED INDICATED THAT "THE DEATH WAS CARDIAC ARREST MOST LIKELY DUE TO LIDOCAINE TOXICITY." THE CUSTOMER STATED THAT LIDOCAINE QUALITY CONTROL RESULTS WERE WITHIN LABORATORY REFERENCE RANGES ON THE DATE OF TESTING. STATEMENTS AND ACTIONS ATTRIBUTED TO THE PHYSICIAN(S) AND CUSTOMER ARE DERIVED FROM THE INFORMATION SUPPLIED BY THE CUSTOMER TO SIEMENS, DOCUMENTED IN SIEMENS COMPLAINT HANDLING SYSTEM AND HAVE NOT BEEN VERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24455 SYVA® EMIT SYVA® EMIT LIDOCAINE ASSAY KLR SIEMENS HEALTHCARE DIAGNOSTICS INC. 10445369 M1 00842768001390

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death