BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT EC8+ CARTRIDGE

    MDR report key: 8615337 · Received May 16, 2019

    Report

    Report Number
    2245578-2019-00126
    Event Type
    Malfunction
    Date Received
    May 16, 2019
    Date of Event
    May 8, 2019
    Report Date
    July 22, 2019
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    CHL
    UDI-DI
    10054749000071
    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 # (B)(4). THE INVESTIGATION WAS COMPLETED ON 07/18/2019. 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 EC8+ LOT K19018.

    Additional Manufacturer Narrative · 1

    (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 EC8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT PH (7.659) AND BE (6MMOL/L) RESULTS ON AN (B)(6) MALE PATIENT WITH TENTATIVE DIAGNOSIS OF PNEUMONIA. THE CUSTOMER STATES THAT THE BE RESULT REVEALS METABOLIC ALKALOSIS, BUT HCO3 RESULT IS NORMAL. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. (B)(6). THERE WERE NO TEST/COLLECTION TIMES REPORTED. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THERE WAS NO REPEAT ON I-STAT OR ALTERNATE METHOD. THE CUSTOMER STATES THAT RESULTS ARE NOT CONSISTENT WITH THE PATIENT'S CLINICAL PICTURE. THE INVESTIGATION IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411211 I-STAT EC8+ CARTRIDGE EC8+ CARTRIDGE CHL ABBOTT POINT OF CARE NA K19018 10054749000071

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO