BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT EG7+ CARTRIDGE

    MDR report key: 8503165 · Received April 11, 2019

    Report

    Report Number
    2245578-2019-00089
    Event Type
    Malfunction
    Date Received
    April 11, 2019
    Date of Event
    March 20, 2019
    Report Date
    May 28, 2019
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    CHL
    UDI-DI
    10054749000040
    PMA / PMN Number
    K940918
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT # (B)(4). THE INVESTIGATION WAS COMPLETED ON 05/28/2019. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THE CARTRIDGE LOT MET FINISHED GOODS (FG) RELEASE CRITERIA. RETAINED TESTING MET THE ACCEPTANCE CRITERIA OUTLINED IN APPENDIX 1 OF Q04.01.003 REV. AD (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE). NO DEFICIENCY HAS BEEN DETERMINED FOR EG7+ LOT N18331.

    Additional Manufacturer Narrative · 1

    APOC INCIDENT #: (B)(4). APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2019, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT EG7+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT POTASSIUM AND IONIZED CALCIUM RESULTS ON AN (B)(6) YEAR OLD MALE PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. (B)(6). AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE ICA (IONIZED CALCIUM) RESULT REPORTED ON THE I-STAT WAS 0.86 MMOL/L FROM A WHOLE BLOOD SAMPLE. THE TCA (TOTAL CALCIUM) RESULT REPORTED BY THE LAB INSTRUMENT (TYPE: UNKNOWN) WAS 2.7 MMOL/L FROM A SERUM SAMPLE. ABOUT 50% OF TOTAL CALCIUM FOUND IN A SERUM SAMPLE EXISTS IN A FREELY IONIZED FORM. ADDITIONALLY, SERUM PRODUCES AN ICA APPROXIMATELY 0.05 MMOL/L HIGHER THAN A WHOLE BLOOD SAMPLE. THEREFORE, THE ICA RESULT CORRESPONDING TO THE LAB RESULT OF 2.7 MMOL/L IS ESTIMATED TO BE 1.30 MMOL/L (2.7 *50% - 0.05). THE INVESTIGATION IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295995 I-STAT EG7+ CARTRIDGE EG7+ CARTRIDGE CHL ABBOTT POINT OF CARE NA N18331 10054749000040

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR