BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYVA® EMIT 2000

    MDR report key: 2763520 · Received September 27, 2012

    Report

    Report Number
    2517506-2012-00261
    Event Type
    Malfunction
    Date Received
    September 27, 2012
    Date of Event
    August 31, 2012
    Report Date
    August 31, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    DLZ
    PMA / PMN Number
    K913190
    Removal / Correction Number
    2517506-07-30-2012-014-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE IMPRECISE EMIT(R) PHNO RESULTS IS UNKNOWN. NOTE: THE ACCOUNT IS RUNNING THE EMIT(R) PHNO REAGENT ON AN INSTRUMENT SYSTEM (JOEL BIOMAJESTY-6050) FOR WHICH SIEMENS HEALTHCARE DIAGNOSTICS DOES NOT SUPPLY AN APPLICATION. HOWEVER, THE BIOMAJESTY INSTRUMENT IS SIMILAR TO (BUT NOT IDENTICAL WITH) THE SIEMENS ADVIA SYSTEM WHICH DOES HAVE A SIEMENS SUPPORTED APPLICATION FOR THE SYVA EMIT(R) PHNO REAGENT. SIMILAR IMPRECISION HAS BEEN NOTED FOR LOT E1 ON THE SIEMENS ADVIA SYSTEM. THE ISSUE WITH THE REAGENT IS UNDER ACTIVE INVESTIGATION AT SIEMENS. INFORMATION SUPPLIED BY THE CUSTOMER THAT OTHER EMIT(R) REAGENTS ARE PERFORMING WITHIN PRECISION EXPECTATIONS ON THE SAME INSTRUMENT INDICATE THAT THE INSTRUMENT IS LIKELY PERFORMING WITHIN SPECIFICATIONS. THE EMIT(R) PHNO IMPRECISION ISSUE IS UNDER INVESTIGATION AT SIEMENS HEALTHCARE DIAGNOSTICS INC.

    Additional Manufacturer Narrative · 1

    (B)(4).ADDITIONAL INFORMATION:SIEMENS HEALTHCARE DIAGNOSTICS INC. ISSUED AN URGENT MEDICAL DEVICE RECALL ON (B)(4)-2012. THE RECALL LETTER CONFIRMED THE COMPLAINT OF IMPRECISION AND OUTLIERS WITH THE EMIT(R) 2000 PHENOBARBITAL ASSAY LOTS D7, E1, E2, AND E3. THE RECALL LETTER INSTRUCTED CUSTOMERS TO IMMEDIATELY DISCARD ANY REMAINING REAGENT INVENTORY OF LOTS D7, E1, E2, AND E3 AND TO CONTACT SIEMENS HEALTHCARE DIAGNOSTICS FOR REPLACEMENT WITH NON-IMPACTED LOTS.

    Additional Manufacturer Narrative · 1

    ORIGINAL MDR WAS SUBMITTED (B)(6) 2012. SIIEMENS HEALTHCARE DIAGNOSTICS HAS IDENTIFIED THE ROOT CAUSE OF THE IMPRECISION AND IMPLEMENTED CORRECTIVE AND PREVENTIVE ACTIONS. IT HAS BEEN DETERMINED THAT AGGREGATION OF GLUCOSE-6-PHOSPHATE DEHYDROGENASE (G6PDH) ANTIBODY CAUSED THE IMPRECISION. SIEMENS HEALTHCARE DIAGNOSTICS HAS QUALIFIED THE REMOVAL OF THE G6PDH ANTIBODY FROM THE REAGENT, VALIDATED, AND IMPLEMENTED THE CHANGE.

    Description of Event or Problem · 1

    IMPRECISE PHENOBARBITAL (PHNO) RESULTS WERE OBTAINED ON QC AND PATIENT SAMPLES WITH TWO LOTS OF REAGENT. IT IS UNKNOWN IF PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN. THE ACCOUNT DOES NOT BELIEVE THEY HAVE REPORTED ANY INCORRECT RESULTS. THE ACCOUNT COMPLAINS OF IMPRECISION WITH THE QC SAMPLES. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED ON THE BASIS OF THE IMPRECISE PHNO RESULTS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE IMPRECISE PHNO RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYVA® EMIT 2000 PHENOBARBITAL ASSAY DLZ SIEMENS HEALTHCARE DIAGNOSTICS INC E1

    Patients

    Seq Age Sex Outcome Treatment
    1