BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA(R) CLINICAL CHEMISTRY SYSTEM

    MDR report key: 3605064 · Received February 4, 2014

    Report

    Report Number
    2517506-2014-00016
    Event Type
    Malfunction
    Date Received
    February 4, 2014
    Date of Event
    October 21, 2013
    Report Date
    January 9, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    JIX
    PMA / PMN Number
    K061923
    Removal / Correction Number
    2517506-01-16-2014-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS HAS CONFIRMED COMPLAINTS REGARDING QUALITY CONTROL (QC) SHIFTS WITH PSEUDOCHOLINESTERASE (PCHE) AND IMPRECISION DURING PCHE CALIBRATION WITH DIMENSION VISTA® ENZYME 1 CALIBRATOR (ENZ 1 CAL) LOTS 3FD034 AND 3HD012. INVESTIGATION BY SIEMENS CONFIRMS A LOSS OF PCHE ACTIVITY IN THE AFFECTED LOTS OF ENZYME 1 CALIBRATOR, CAUSING AN ELEVATION OF QC BY AS MUCH AS 80% AND IN SOME INSTANCES, IMPRECISION OF REPLICATES DURING CALIBRATION. QC WILL DETECT ELEVATED PCHE RESULTS FOLLOWING CALIBRATION, AND IN THESE CASES NO PATIENT RESULTS WILL BE REPORTED. SIEMENS ISSUED AN URGENT MEDICAL DEVICE CORRECTION COMMUNICATION 14-01 DATED JANUARY 2014 TO CUSTOMERS WHO HAD ORDERED THESE LOTS ADVISING THEM TO DISCONTINUE THE USE OF LOTS 3FD034 AND 3HD012 TO CALIBRATE PCHE. DIMENSION VISTA® ENZ 1 CAL (CATALOG # KC310) LOTS 3FD034 AND 3HD012 CAN BE USED TO CALIBRATE THE OTHER ANALYTES LISTED IN THE IFU: AMYLASE (AMY), GAMMA-GLUTAMYL TRANSFERASE (GGT), LACTATE DEHYDROGENASE (LDH), AND LIPASE (LIPL). SIEMENS HAS CONFIRMED ACCEPTABLE PERFORMANCE OF THESE ENZYMES WITH LOTS 3FD034 AND 3HD012.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED A QC SHIFT HIGH AND IMPRECISION AFTER CALIBRATION OF THE PSEUDOCHOLINESTERASE (PCHE) REAGENT AFTER CALIBRATION WITH DIMENSION VISTA(R) ENZ I CALIBRATOR KC310 LOT 3FD034. RECOVERIES ABOVE LABORATORY RANGES WERE OBTAINED WITH TWO DIFFERENT LOTS OF PCHE FLEX(R) REAGENT CARTRIDGES. RECOVERIES ABOVE LABORATORY RANGE WERE AGAIN OBTAINED WHEN CALIBRATION WAS CONDUCTED WITH ALTERNATE ENZ 1 CAL LOT 3HD012. IT IS UNKNOWN IF PATIENT RESULTS WERE REPORTED WHILE QC WAS OUT OF RANGE. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED ON THE BASIS OF FALSELY ELEVATED PCHE RESULTS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED PCHE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72734 DIMENSION VISTA(R) CLINICAL CHEMISTRY SYSTEM ENZYME 1 CALIBRATOR JIX SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW 3FD034

    Patients

    Seq Age Sex Outcome Treatment
    1