BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT EG7+ CARTRIDGE

    MDR report key: 12304888 · Received August 10, 2021

    Report

    Report Number
    2245578-2021-00063
    Event Type
    Malfunction
    Date Received
    August 10, 2021
    Date of Event
    July 31, 2021
    Report Date
    August 19, 2021
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    CHL
    UDI-DI
    10054749000040
    PMA / PMN Number
    K940918
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: # 866308. THE INVESTIGATION WAS COMPLETED ON 17-AUG-2021. A REVIEW OF THE DEVICE HISTORY RECORDS (DHRS) CONFIRMED THE CARTRIDGE LOTS MET FINISHED GOODS (FG) RELEASE CRITERIA. THE TARGETS FOR TRIL2 LOT 311132 AND TRICONTROLS CALIBRATION VERIFICATION LEVEL 3 (TRICV3) FROM CALIBRATION VERIFICATION SET LOT 20245 LOT 311132 WERE RELEASED UNDER DCP-0003253. THE TARGETS FOR TRIL2 LOT 311136 AND TRICV3 FROM CALIBRATION VERIFICATION SET LOT 20336 LOT 311136 WERE RELEASED UNDER DCP-0003253. THE ICA TARGETS WERE REVIEWED AND FOUND TO MATCH THE ICA VALUES PUBLISHED IN THE RESPECTIVE ARTWORKS. RETAINED TESTING MET THE ACCEPTANCE CRITERIA FOUND IN Q04.01.003 REV. AG, APPENDIX 1 - PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE. RETURNED CARTRIDGES TESTING DID NOT REPRODUCE THE CUSTOMER'S OBSERVATION. NO DEFICIENCY HAS BEEN DETERMINED FOR EG7+ CARTRIDGE LOTS N21003 AND N21100 OR TRIL2 AND TRICV3 LOT 311132 AND TRIL2 AND TRICV3 LOT 311136.

    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) 2021, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT EG7+ CARTRIDGES THAT YIELDED SUSPECTED DESCREPANT IONIZED CALCIUM RESULTS OF 1.30 AND 1.83 MMOL/L. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. 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 INVESTIGATION IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1196243 I-STAT EG7+ CARTRIDGE EG7+ CARTRIDGE CHL ABBOTT POINT OF CARE NA N21100 10054749000040

    Patients

    Seq Age Sex Outcome Treatment
    1