BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 4101848 · Received September 19, 2014

    Report

    Report Number
    2517506-2014-00341
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    DIP
    PMA / PMN Number
    K911056
    Removal / Correction Number
    2517506-09/24/2014-005-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS HAS CONFIRMED CUSTOMER COMPLAINTS OF IMPRECISION AND INACCURACY WITH PTN FLEX LOT FA5154. INTERNAL TESTING HAS CONFIRMED A LOW ABSORBANCE RANGE BETWEEN THE LEVELS 1 AND 5 CALIBRATORS WITH THIS LOT CAN RESULTING IN THE POTENTIAL FOR A POSITIVE OR NEGATIVE BIAS AND IMPRECISION ACROSS THE PTN ASSAY RANGE. INTERNAL STUDIES DEMONSTRATED THE BIAS IS VARIABLE ACROSS THE ASSAY RANGE FROM 9-38%. THE HIGHEST DEGREE OF BIAS IS OBSERVED BELOW THE THERAPEUTIC RANGE OF 10-20 UG/ML (39.6-79.2 UMOL/L). THE REAGENT BLANK ABSORBANCE FOR PTN LOT FA5154 MAY ALSO GENERATE ABNORMAL REACTION FLAGS. SIEMENS ISSUED AN URGENT MEDICAL DEVICE RECALL COMMUNICATION (B)(4) DATED (B)(6) 2014 TO CUSTOMERS WHO HAD ORDERED PTN LOT FA5154 ADVISING THEM TO DISCONTINUE THE USE OF THE LOT. SIEMENS OFFERED A NO CHARGE REPLACEMENT WITH A NON-IMPACTED LOT OF PHENYTOIN FLEX REAGENT CARTRIDGES.

    Additional Manufacturer Narrative · 1

    ORIGINAL MDR WAS SUBMITTED 09/19/2014. AS A RESULT OF INVESTIGATIONS, SIEMENS HEALTHCARE DIAGNOSTICS HAS CONFIRMED CUSTOMER COMPLAINTS OF IMPRECISION AND INACCURACY WITH PTN FLEX LOT FA5154. INTERNAL TESTING HAS CONFIRMED A LOW ABSORBANCE RANGE BETWEEN THE LEVELS 1 AND 5 CALIBRATORS WITH THIS LOT CAN RESULTING IN THE POTENTIAL FOR A POSITIVE OR NEGATIVE BIAS AND IMPRECISION ACROSS THE PTN ASSAY RANGE. INTERNAL STUDIES DEMONSTRATED THE BIAS IS VARIABLE ACROSS THE ASSAY RANGE FROM 9-38%. THE HIGHEST DEGREE OF BIAS IS OBSERVED BELOW THE THERAPEUTIC RANGE OF 10-20 UG/ML (39.6-79.2 UMOL/L). THE REAGENT BLANK ABSORBANCE FOR PTN LOT FA5154 MAY ALSO GENERATE ABNORMAL REACTION FLAGS. SIEMENS ISSUED AN URGENT MEDICAL DEVICE RECALL COMMUNICATION 14-63 DATED SEPTEMBER 2014 TO CUSTOMERS WHO HAD ORDERED PTN LOT FA5154 ADVISING THEM TO DISCONTINUE THE USE OF THE LOT. SIEMENS OFFERED A NO CHARGE REPLACEMENT WITH A NON-IMPACTED LOT OF PHENYTOIN FLEX REAGENT CARTRIDGES.

    Description of Event or Problem · 1

    DISCREPANT PHENYTOIN (PTN) RESULTS WERE OBTAINED DURING AN ATTEMPTED CALIBRATION OF LOT FA5154. ALL RESULTS WERE FLAGGED AS ABNORMAL REACTION ERRORS. THE CALIBRATION WAS NOT ACCEPTED AND PATIENT RESULTS WERE NOT REPORTED TO PHYSICIANS. THERE IS NO INDICATION THAT PATIENT TREATMENT WAS ALTERED OR PRESCRIBED ON THE BASIS OF DISCREPANT PTN RESULTS AND FAILURE TO CALIBRATE. THERE IS NO INDICATION OF ADVERSE IMPACT TO PATIENTS DUE TO THE FAILURE TO CALIBRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581680 DIMENSION® CLINICAL CHEMISTRY SYSTEM PHENYTOIN FLEX® REAGENT CARTRIDGE DIP SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW

    Patients

    Seq Age Sex Outcome Treatment
    1