BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2517506-2017-00392

    MDR report key: 6490928 · Received April 13, 2017

    Report

    Report Number
    2517506-2017-00392
    Event Type
    Malfunction
    Date Received
    April 13, 2017
    Date of Event
    March 22, 2017
    Report Date
    June 28, 2017
    PMA / PMN Number
    K130276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2517506-2017-00392 WAS FILED ON APRIL 13, 2017. THE FIRST SUPPLEMENTAL MDR 2517506-2017-00392_S1 WAS FILED ON MAY 26, 2017. ADDITIONAL INFORMATION (06/06/2017): A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST REVIEWED THE INFORMATION PROVIDED BY THE CUSTOMER. THE HSC SPECIALIST STATED THAT REPEAT RESULTS FOR THE PATIENT SAMPLE WAS OUTSIDE OF THE EXPECTED REFERENCE RANGE FOR THE LACTATE DEHYDROGENASE (LDI) ASSAY, WHICH WAS DIFFERENT FROM QUALITY CONTROL PERFORMANCE. LEVEL 1 QUALITY CONTROL WAS INITIALLY HIGH AND WITHIN RANGE POST CALIBRATION. HOWEVER, THE PATIENT RESULTS WENT IN THE OPPOSITE DIRECTION. THE ISSUE WAS RESOLVED WITH MAINTENANCE AND CALIBRATION OF LDI. THE CAUSE OF THE DISCORDANT, FALSELY LOW LDI RESULT ON ONE PATIENT SAMPLE AND LEVEL 1 QUALITY CONTROL BEING OUT OF RANGE IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2517506-2017-00392 WAS FILED ON APRIL 13, 2017. ADDITIONAL INFORMATION (05/02/2017): A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) REVIEWED THE INFORMATION PROVIDED BY THE CUSTOMER AND STATED THE CUSTOMER HAD PERFORMED REPEAT TESTING FOR THE SAMPLE IN QUESTION AFTER REFRIGERATING IT. THE DIMENSION LACTATE DEHYDROGENASE (LDI) INSTRUCTIONS FOR USE UNDER THE SECTION OF SPECIMEN COLLECTION AND HANDLING STATES, "SEPARATED SERUM/PLASMA SAMPLES ARE STABLE FOR 3 DAYS AT 20 - 25 °C. DO NOT REFRIGERATE OR FREEZE". FOR LDI ASSAY, THE RESULTS INCREASE IF THE SAMPLES ARE REFRIGERATED. BASED ON A SIEMENS CUSTOMER SERVICE SPECIALIST'S OBSERVATIONS, THE REPEAT RESULTS ARE CONSIDERED INCORRECT. THE ISSUE WAS RESOLVED BY CALIBRATING TEMPERATURES.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) AND STATED THAT THEIR LEVEL 1 QUALITY CONTROL FOR LDI WAS OUT OF RANGE. THE CUSTOMER PERFORMED CALIBRATION AND REPEATED QUALITY CONTROL, WHICH WAS ACCEPTABLE. AFTER QUALITY CONTROL WAS WITHIN RANGE, THE CUSTOMER REPEATED THE PATIENT SAMPLE, WHICH RESULTED DIFFERENT FROM THE INITIAL RESULT. THE CCC SPECIALIST DIALED INTO THE SYSTEM REMOTELY AND PERFORMED PHOTOMETER ARM ALIGNMENT AND MILI AMPLIFIER UNIT OFFSET CALIBRATION. THE CAUSE OF THE DISCORDANT, FALSELY LOW LDI RESULT ON ONE PATIENT SAMPLE AND LEVEL 1 QUALITY CONTROL BEING OUT OF RANGE IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY LOW LACTATE DEHYDROGENASE (LDI) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION EXL WITH LM INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED TWICE ON THE SAME INSTRUMENT, RESULTING HIGHER BOTH TIMES. THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT, FALSELY LOW LDI RESULT.

    Patients

    Seq Age Sex Outcome Treatment
    1