BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIGLYCERIDES_2 REAGENT, CONCENTRATED

    MDR report key: 5492114 · Received March 10, 2016

    Report

    Report Number
    2432235-2016-00124
    Event Type
    Malfunction
    Date Received
    March 10, 2016
    Date of Event
    March 1, 2016
    Report Date
    March 2, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    CDT
    PMA / PMN Number
    K133067
    Removal / Correction Number
    2432235-03/09/2016-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2432235-2016-00124 WAS FILED ON 3/10/2016. CORRECTED INFORMATION: IN THE INITIAL MDR THE DATE OF EVENT WAS INDICATED AS (B)(6) 2016. THE CUSTOMER HAS INFORMED SIEMENS DIAGNOSTICS ON (B)(6) 2016, THAT THE CORRECT DATE OF EVENT IS (B)(6) 2016. ADDITIONAL INFORMATION (3/16/2016): IN THE INITIAL MDR IT WAS UNKNOWN IF THE PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE CUSTOMER HAS INFORMED SIEMENS HEALTHCARE THAT RESULTS ABOVE 400 NG/DL WERE NOT REPORTED TO PHYSICIANS(S). THE CUSTOMER CONFIRMS ALL SAMPLES >400 NG/D WITH DILUTIONS.

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS HAS CONFIRMED THE TRIG_C REAGENT KIT LOTS 348297 AND 359932( SMN (B)(4)) USED ON THE ADVIA® 1200, 1650, 1800, 2400, AND XPT CHEMISTRY SYSTEMS DOES NOT MEET INSTRUCTIONS FOR USE (IFU) LINEARITY CLAIM AT THE UPPER LIMIT OF THE ASSAY RANGE AS IT APPROACHES END OF SHELF LIFE. INTERNAL TESTING DEMONSTRATED THAT A PATIENT BIAS (-12% TO -15%) MAY BE SEEN AT CONCENTRATION LEVELS BETWEEN 450 TO 550MG/DL. LINEARITY IS REDUCED BY APPROXIMATELY 31% AT HIGHER TRIGLYCERIDE CONCENTRATIONS UP TO 1200MG/DL (13.56MMOL/L). AN URGENT FIELD SAFETY NOTICE (UFSN) (B)(4)OUS WAS SENT TO OUS CUSTOMERS AND A URGENT MEDICAL DEVICE RECALL (UMDR) CHC16-03.A.US WAS SENT TO US CUSTOMERS IN (B)(6) 2016. THE UFSN AND UMDR STATE THAT CUSTOMERS ARE TO DISCONTINUE USE AND DISCARD REAGENT KIT LOTS 348297 AND 359932.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2432235-2016-00124 WAS FILED ON 3/10/2016. THE DATES WERE INCORRECTLY LISTED AS (B)(6) 2016 AND 03/02/2016 IN THE EVENT DATE AND REPORT DATE FIELDS RESPECTIVELY. THE CORRECT DATES ARE 03/02/2016 FOR REPORT DATE AND 02/29/2016 FOR DATE RECEIVED BY MFR.

    Description of Event or Problem · 1

    RESULTS ABOVE 400 NG/DL WERE NOT REPORTED TO PHYSICIANS(S). THE CUSTOMER CONFIRMS ALL SAMPLES >400 NG/D WITH DILUTIONS.

    Description of Event or Problem · 1

    THE CUSTOMER HAS OBSERVED THAT THE LINEARITY CLAIMS FOR THE TRIGLYCERIDES_2 CONCENTRATED ASSAY ARE NOT BEING MET WHEN USING REAGENT LOT 348297 ON THE ADVIA CHEMISTRY 2400 INSTRUMENT. HIGH PATIENT SAMPLES WHEN DILUTED REPORT RESULTS HIGHER THAN THE RESULT OBTAINED ON A SAMPLE WHEN RUN NEAT. THE HIGH RESULT OBTAINED ON THE DILUTED PATIENT SAMPLE MATCHES WITH THE EXPECTED RESULT. IT IS UNKNOWN IF THE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE TRIG_C ASSAY NOT MEETING LINEARITY CLAIMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147943 TRIGLYCERIDES_2 REAGENT, CONCENTRATED TRIGLYCERIDES_2 REAGENT, CONCENTRATED CDT SIEMENS HEALTHCARE DIAGNOSTICS, INC. TRIGLYCERIDES_2 REAGENT, CONCENTRATED 348297

    Patients

    Seq Age Sex Outcome Treatment
    1