BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 1000 VITAMIN B12

    MDR report key: 8217112 · Received January 4, 2019

    Report

    Report Number
    2432235-2019-00003
    Event Type
    Malfunction
    Date Received
    January 4, 2019
    Date of Event
    December 17, 2018
    Report Date
    January 4, 2019
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED
    Product Code
    LIG
    UDI-DI
    00630414964874
    PMA / PMN Number
    K993251
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS INVESTIGATED THE EVENT AND DETERMINED THE OPERATOR DID NOT FOLLOW THE INSTRUCTIONS IN THE IMMULITE/IMMULITE 1000 VITAMIN B12 INSTRUCTIONS FOR USE, WHICH INSTRUCTS THE USER TO USE EXTREME CARE TO AVOID ALL BODILY CONTACT WITH THIS REAGENT, DUE TO THE PRESENCE OF CYANIDE. IN ADDITION, THE SAFETY DATA SHEET INDICATES THE INDIVIDUAL PROTECTION MEASURES FOR SKIN PROTECTION WHEN USING THIS PRODUCT. THE OPERATOR WAS NOT WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) WHEN USING THE VITAMIN B12 BORATE KCN BUFFER SOLUTION. THE CAUSE OF THE EVENT WAS DUE TO THE OPERATOR NOT FOLLOWING THE INSTRUCTIONS IN THE INSTRUCTIONS FOR USE OR THE SAFETY DATA SHEETS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE SYSTEM IS PERFORMING WITHIN MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    SIEMENS WAS INFORMED THAT WHILE USING THE VITAMIN B12 BORATE KCN BUFFER SOLUTION, 20-30 ML OF THE BUFFER SPILLED ON THE OPERATOR'S LEGS. THE OPERATOR'S SKIN WAS RED AT THE SITE OF THE BUFFER CONTACT AREA BUT FADED AFTER A SHORT PERIOD OF TIME. THE CUSTOMER INFORMED SIEMENS THAT THE OPERATOR WAS WEARING GLOVES AT THE TIME OF USE. THE OPERATOR CONSULTED A PHYSICIAN(S). IT IS UNKNOWN IF ANY MEDICAL TREATMENT WAS RENDERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE SPILL OF THE BUFFER SOLUTION ON THE OPERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11971 IMMULITE 1000 VITAMIN B12 IMMULITE 1000 VITAMIN B12 LIG SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 1000 UNKNOWN 00630414964874

    Patients

    Seq Age Sex Outcome Treatment
    1