BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA®

    MDR report key: 6368487 · Received March 1, 2017

    Report

    Report Number
    9610806-2017-00035
    Event Type
    Malfunction
    Date Received
    March 1, 2017
    Date of Event
    February 2, 2017
    Report Date
    June 5, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    CHN
    PMA / PMN Number
    K063655
    Removal / Correction Number
    9610806-05-25-2017-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ORIGINAL MDR 9610806-2017-00035 WAS FILED 3/1/2017. SUPPLEMENT FILED TO CORRECT ENTRY IN WHICH HAD INCORRECTLY BEEN ENTERED AS 2/28/2017.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER WITH AN INQUIRY ON BIASED LOW CERULPLASMIN RESULTS OVER A PERIOD OF TIME. THE DESCRIBED INCIDENT AFFECTS AN UNKNOWN NUMBER OF PATIENT SAMPLES AND THE CLINICAL CONTEXT OF THE SAMPLES IS UNKNOWN. PER THE DIMENSION VISTA INSTRUCTIONS FOR USE, MEASUREMENTS OF CERULOPLASMIN ARE INTENDED AS AN AID IN THE DIAGNOSIS OF COPPER METABOLISM DISORDERS. CERULOPLASMIN IS THE MAIN TRANSPORT PROTEIN FOR COPPER IN THE BLOOD. IN WILSON'S DISEASE AND MENKE'S SYNDROME, THE SERUM CERULOPLASMIN ARE MARKEDLY DIMINISHED. LOW LEVELS OF CRULOPLASMIN ALSO OCCUR IN PATIENTS WITH HEPATIC INSUFFICIENCY AND PROTEIN LOSS SYNDROME. THEREFORE, PATHOLOGICAL CERULOPLASMIN RESULTS SHOULD TRIGGER FURTHER NON-INVASIVE TESTS (E.G. LIVER BLOOD-BASED BIOMARKERS) BEFORE PERFORMING LIVER BIOPSIES. HOWEVER, INTERNAL INVESTIGATION ON LOT PERFORMANCE HAS BEEN INITIATED AND IS ONGOING.

    Additional Manufacturer Narrative · 1

    ORIGINAL MDR 9610806-2017-00035 WAS FILED 3/1/2017. MDR 9610806-2017-00035 SUPPLEMENT 1 WAS FILED 3/1/2017 (SUPPLEMENT FILED TO CORRECT ENTRY IN REPORT DATE WHICH HAD INCORRECTLY BEEN ENTERED AS 2/28/2017). SIEMENS HEALTHINEERS HEADQUARTERS SUPPORT CENTER (HSC) COMPLETED AN INVESTIGATION OF THE ISSUE. WITHIN THE INVESTIGATIONS, A DEVIATION IN THE VALUE ASSIGNMENT OF THE AFFECTED STANDARD OF DIMENSION VISTA PROT1 CAL AND PROT1 CON L /CON M / CON H CONTROL LOTS USED WITH THE DIMENSION VISTA CERULOPLASMIN (CER) FLEX REAGENT CARTRIDGE WAS IDENTIFIED. THIS IS LEADING TO LOWER RESULTS COMPARED TO CORRECTLY ASSIGNED STANDARDS. AN URGENT MEDICAL DEVICE CORRECTION HAS BEEN IMPLEMENTED ADVISING CUSTOMERS TO USE CORRECTED ASSIGNED VALUES AND/OR ACCEPTANCE RANGES FOR THE AFFECTED LOTS OF CALIBRATORS AND CONTROLS. URGENT MEDICAL DEVICE CORRECTION BR-04017-OUS DATED MAY 2017 AND URGENT MEDICAL DEVICE CORRECTION PP-17-012.A.US COMMUNICATIONS DATED MAY 23, 2017 WERE MAILED TO CUSTOMERS WHO HAD BEEN SHIPPED THE CERULOPLASMIN (CER) FLEX REAGENT CARTRIDGE. SIEMENS HEALTHINEERS HAS ASSIGNED CORRECT VALUES TO THE IMPACTED LOTS OF CALIBRATORS AND CONTROLS WHERE SUFFICIENT MATERIAL WAS AVAILABLE FOR A NEW VALUE ASSIGNMENT. THESE LOTS OF CALIBRATORS AND CONTROLS CAN BE USED FOR DETERMINATION OF CERULOPLASMIN WITH THE REVISED ASSIGNED VALUES AND ACCEPTANCE RANGES. CUSTOMERS WERE INSTRUCTED TO NOT USE THE IMPACTED LOTS OF PROT1 CAL AND PROT1 CON L /CON M / CON H CONTROL FOR CER WHERE NO CORRECTED TARGET VALUES AND ACCEPTANCE RANGES WERE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER NOTIFIED SIEMENS OF DISCORDANT LOW RESULTS FOR CERULOPLASMIN (CER) ON PATIENT SAMPLES ON THE DIMENSION VISTA 1500 INTERNATIONAL INSTRUMENT OVER A PERIOD OF TIME. THEY REGARDED RECENT RESULTS AS NOT IN CONCORDANCE WITH THE PRESENCE OF IRON DEPOSITS IN BIOPSIES OR WILSON DISEASE DIAGNOSTICS BY GENETIC STUDY. THE HEPATOLOGY UNIT IN THE HOSPITAL REVIEWED ANNUAL MEAN PATIENT RESULTS ON THE DIMENSION VISTA FROM 2014 TO THE PRESENT. THEY STATED THAT THEY OBSERVED A PROGRESSIVE INCREASE IN THE PERCENTAGE OF PATIENT RESULTS <20 MG/DL THAT CAN'T BE EXPLAINED BY VARIATIONS IN PATIENTS ATTENDED TO AT THE HOSPITAL OR MODIFICATIONS IN PROTOCOLS. USING THE CER FLEX REAGENT CARTRIDGES, THE CUSTOMER COMPLAINS ABOUT AN INCREASE OF PATHOLOGICALLY LOW PATIENT RESULTS. THE CUTOFF OF 20 MG/DL IS COMMONLY USED FOR DIAGNOSTICS OF WILSON DISEASE AND MENKE'S SYNDROME. THE CER FLEX REAGENT INSTRUCTIONS FOR USE SHOWS A REFERENCE RANGE OF 20 - 60 MG/DL. THIS CUSTOMER IS OBSERVING AROUND 38% OF PATIENTS WITH RESULTS <20 MG/DL. FURTHERMORE, THE CUSTOMER STATED THAT HE MAY HAVE SENT PATIENTS FOR UNNECESSARY BIOPSIES. FURTHER INVESTIGATIONS EMERGED THAT SOME PATIENTS DO NOT HAVE RELATED DISEASE. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT LOW CER RESULTS OR BIOPSIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150598 DIMENSION VISTA® DIMENSION VISTA® CER CERULOPLASMIN FLEX® REAGENT CARTRIDGE CHN SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH 16264MA

    Patients

    Seq Age Sex Outcome Treatment
    1