BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA® CHEMISTRY 1 CALIBRATOR

    MDR report key: 5389631 · Received January 25, 2016

    Report

    Report Number
    2517506-2016-00007
    Event Type
    Malfunction
    Date Received
    January 25, 2016
    Date of Event
    December 1, 2015
    Report Date
    September 28, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    JIX
    PMA / PMN Number
    K140790
    Removal / Correction Number
    2517506-09-28-2016-003-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCREPANT LOW CA RESULTS IS DUE TO A LOT TO LOT BIAS OF THE CALIBRATOR LOT CONCURRENT WITH A CHANGE IN REAGENT LOT. SIEMENS HEALTHCARE CONDUCTED AN INVESTIGATION INTO CHEM I CALIBRATOR LOT 5GM082. ALTHOUGH A MINOR NEGATIVE BIAS IN RECOVERY WITH LOT 5GM082 WAS CONFIRMED; THE MAGNITUDE OF THE SHIFT DID NOT EXCEED 0.2 MG/DL AS BASED ON CALIBRATOR TO CALIBRATOR VARIATION. THE INVESTIGATION CONCLUDED THAT THE ROOT CAUSE OF THE DISCREPANT LOW RESULTS IS INCONCLUSIVE, HOWEVER OTHER POTENTIAL FACTORS INCLUDING, BUT NOT LIMITED TO, CALIBRATOR PREPARATION, STORAGE CONDITIONS AND IN SOME INSTANCES, A NEED FOR INSTRUMENT MAINTENANCE, MAY AMPLIFY THE MAGNITUDE OF THE RECOVERY SHIFT OBSERVED AT ACCOUNTS USING THESE CALIBRATOR MATERIALS. SIEMENS RECOMMENDS FOLLOWING THE VISTA CHEM 1 CAL INSTRUCTIONS FOR USE, WHICH PROVIDES FURTHER CLARIFICATION OF BOTH CALIBRATOR STORAGE AND REAGENT PREPARATION IN ORDER TO ENSURE MINIMAL BIAS IS INTRODUCED INTO THE CALIBRATION. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    ORIGINAL MDR 2517506-2016-00007 WAS FILED 01-25-2016. SIEMENS HEALTHCARE DIAGNOSTICS HAS CONFIRMED THAT DIMENSION VISTA® CHEM 1 CAL LOTS 5GM081 (KC110) AND 5GM082 (KC110B) MAY PRODUCE DEPRESSED RESULTS WITH SOME LOTS OF CALCIUM (CA) FLEX REAGENT CARTRIDGES. SIEMENS ISSUED AN URGENT MEDICAL DEVICE RECALL COMMUNICATION TO ALL CUSTOMERS WHO PURCHASED LOT 5GM081 AND 5GM082 ADVISING THEM TO RECALIBRATE WITH AN ALTERNATE LOT OF CHEM 1 CAL IF THEY HAD AN ACTIVE CA CALIBRATION. THE URGENT MEDICAL DEVICE RECALL LETTER VC-16-06.A.US AND URGENT FIELD SAFETY NOTICE VC-16-06.A.OUS WERE DATED SEPTEMBER 19, 2016 AND SEPTEMBER 2016, RESPECTIVELY. C&RR #2517506-09-28-2016-003-R.

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINED OF DISCREPANT LOW CALCIUM (CA) RESULTS OBTAINED ON QC AND PATIENT SAMPLES WITH SWITCH TO AN NEW LOT OF VISTA CHEM I CALIBRATOR. PATIENT RESULTS HAD BEEN REPORTED TO PHYSICIANS. AFTER MOVING TO AN ALTERNATE LOT OF CALIBRATOR, HIGHER RESULT WERE OBTAINED IN ACCORD WITH CUSTOMER EXPECTATIONS AND CORRECTED REPORTS WERE ISSUED. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED ON THE BASIS OF THE DISCREPANT LOW CA RESULTS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCREPANT LOW CA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46387 DIMENSION VISTA® CHEMISTRY 1 CALIBRATOR DIMENSION VISTA® CHEMISTRY 1 CALIBRATOR JIX SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW 5GM082

    Patients

    Seq Age Sex Outcome Treatment
    1