BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CHEMISTRY HEMOGLOBIN A1C_3 CALIBRATOR

    MDR report key: 3986372 · Received August 7, 2014

    Report

    Report Number
    2432235-2014-00433
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    March 24, 2014
    Report Date
    July 22, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LCP
    PMA / PMN Number
    K081895
    Removal / Correction Number
    2432235-08/04/14-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORIGINAL MDR 2432235-2014-00433 WAS FILED ON AUGUST 7, 2014.CORRECTED INFORMATION (08/25/14): UPDATED WITH THE CORRECT 510K NUMBER K081895.

    Additional Manufacturer Narrative · 1

    THE ORIGINAL MDR 2432235-2014-00433 WAS FILED ON AUGUST 7, 2014. THE FIRST FOLLOW UP REPORT WAS FILED ON SEPTEMBER 3, 2014. ADDITIONAL INFORMATION (12/19/14): FINAL ROOT CAUSE: BIAS IN PATIENT SAMPLE AND (B)(4) SURVEY PERFORMANCE WAS NOT DETECTED DUE TO THE INSENSITIVITY IN THE CALIBRATOR AND REAGENT TESTING CONTROL SYSTEM. THE OVERALL CAPABILITY (ERROR BUDGET) OF A1C_3 METHOD WAS NOT SUFFICIENT TO CONSISTENTLY PROVIDE CLINICALLY ACCEPTABLE RESULTS ACROSS ALL REAGENT AND CALIBRATOR LOTS. A KEY COMPONENT OF THE ERROR BUDGET IS THE MANUFACTURING CONTROLS SYSTEM FOR ASSIGNMENT OF THE CALIBRATOR BOTTLE VALUES WHERE THE INACCURACY OF THIS PROCESS IS DUE TO LACK OF STATISTICAL POWER.

    Additional Manufacturer Narrative · 1

    SIEMENS HAS CONFIRMED THAT THE ADVIA CHEMISTRY SYSTEMS A1C_3 METHOD MAY EXHIBIT A PERCENT BIAS OF -9% TO +11% FOR HEMOGLOBIN (HB)A1C SAMPLES WHEN USING A1C_3 CALIBRATOR LOTS 3HD044 AND 3LD068. DEPENDING ON QUALITY CONTROL LIMITS, THIS ISSUE MAY NOT HAVE BEEN DETECTED. AN URGENT MEDICAL DEVICE RECALL (UMDR) 10819262, REV. A WAS SENT TO US CUSTOMERS AND AN URGENT FIELD SAFETY NOTICE (UFSN) 10819261, REV. A WAS SENT TO OUS CUSTOMERS IN AUGUST OF 2014. THE UMDR AND UFSN STATE THAT CUSTOMERS ARE REQUESTED TO DISCONTINUE USE OF AND DISCARD THE CALIBRATOR LOTS LISTED, AND TO REVIEW THE PHYSICIAN'S LETTER SENT ALONG WITH THE UMDR AND UFSN WITH THEIR MEDICAL DIRECTOR.

    Description of Event or Problem · 1

    THE CUSTOMER HAS OBSERVED ELEVATED RESULTS OF CONTROLS AND HEALTHY PATIENTS FOR THE A1C_3 ASSAY ON AN ADVIA 1800 INSTRUMENT WHEN USING CALIBRATOR LOT 3HD044. THE RESULTS IN MOST PATIENT SAMPLES ARE BETWEEN 6-6.5% AND ONLY A FEW PATIENTS ARE LESS THAN 6%. THE PATIENT SAMPLE RESULTS ALSO DID NOT CORRELATE WITH RESULTS OBTAINED ON AN ALTERNATE PLATFORM. THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED RESULTS OBTAINED ON CONTROLS AND PATIENT SAMPLES FOR THE A1C_3 ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464559 ADVIA CHEMISTRY HEMOGLOBIN A1C_3 CALIBRATOR ADVIA CHEMISTRY HEMOGLOBIN A1C_3 CALIBRATOR LCP SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CHEMISTRY A1C_3 CALIBRATOR 3HD044

    Patients

    Seq Age Sex Outcome Treatment
    1