BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFECLINITUBES

    MDR report key: 2546839 · Received April 20, 2012

    Report

    Report Number
    3002807968-2012-00006
    Event Type
    Malfunction
    Date Received
    April 20, 2012
    Date of Event
    February 28, 2012
    Report Date
    March 27, 2012
    Manufacturer
    RADIOMETER MEDICAL APS.
    Product Code
    GIO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON THIS NEONATAL DEPARTMENT THEY HAVE HAD TWO DIFFERENT TYPES OF PLASTIC CAPILLARY TUBES, I.E. SAFECLINITUBES D941P-NA-240-85 X 3, PART NO. 942-891, AND SAFECLINITUBES D957P-70-100 X 1, PART NO. 942-892. THESE TWO TYPES OF PLASTIC CAPILLARIES WERE MIXED UP BY THE USERS (NURSES AND PHYSICIANS) WHEN BLOOD SAMPLE MEASUREMENTS HAVE BEEN PERFORMED. THEY HAVE USED THE CAPILLARY TYPE WHICH CONTAINS SODIUM HEPARIN WHEN THEY PERFORMED BLOOD SAMPLE MEASUREMENTS TO GET ELECTROLYTE RESULTS. THIS IS A USE ERROR. WE HAVE REVIEWED THE PACKAGE LABELING AND INSERT FOR THE SAFECLINITUBES (ATTACHED). BOTH THE PACKAGE AND THE INSERT STATES WHICH TYPE OF HEPARIN THE TUBES CONTAIN. FURTHERMORE THE ABL835 ANALYZER OPERATORS MANUAL CONTAINS THE FOLLOWING CAUTION (P. 1-5 'LIMITATIONS OF USE AND KNOWN INTERFERING SUBSTANCES,'): 'ANTICOAGULANTS THAT CONTAIN SODIUM SALTS WILL GIVE ERRONEOUSLY HIGH CNA+ RESULTS. SODIUM FLUORIDE WITH OR WITHOUT EDTA AND OXALATE (DI NA) INFLUENCE CGLU RESULTS. SODIUM FLUORIDE GIVES ERRONEOUSLY HIGH CNA+ AND LOW CCA2+, CGLU AND CLAC RESULTS. TRI SODIUM CITRATE INFLUENCES CNA+, CK+ AND CGLU RESULTS.'

    Description of Event or Problem · 1

    AN ABL835 ANALYZER REPORTED RESULTS OF BLOOD SAMPLE MEASUREMENTS OF NEONATAL PTS WITH AN INCREASED CA VALUE OF APP. 0, 3 MMOL/L HIGHER THAN EXPECTED WHEN MEASUREMENTS WERE PERFORMED ON CAPILLARY BLOOD SAMPLES USING RADIOMETER PLASTIC CAPILLARY TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFECLINITUBES PLASTIC CAPILLARY TUBES GIO RADIOMETER MEDICAL APS. D941P-NA-240-85 X 3 DW 01

    Patients

    Seq Age Sex Outcome Treatment
    1