BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT EC8+ CARTRIDGE

    MDR report key: 6752561 · Received July 28, 2017

    Report

    Report Number
    2245578-2017-00078
    Event Type
    Malfunction
    Date Received
    July 28, 2017
    Date of Event
    February 27, 2017
    Report Date
    July 28, 2017
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    CHL
    UDI-DI
    10054749002266
    PMA / PMN Number
    K940918
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    APOC INCIDENT # (B)(4). APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT. THE INVESTIGATION WAS COMPLETED ON 06/29/2017. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE CARTRIDGE LOT MET FINISHED GOODS RELEASE CRITERIA. RETAINED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA OUTLINED IN APPENDIX 1 OF Q04.01.003 REV. AA (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE). RETURN TESTING DID NOT MEET THE SUPPRESSED RESULTS ACCEPTANCE CRITERIA OUTLINED IN APPENDIX 1 OF Q04.01.003 REV. AA (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE) DUE TO A HIGH RATE OF K+ STAR-OUTS. A DEFICIENCY HAS BEEN DETERMINED FOR EC8+ CARTRIDGE LOT K16342. ER 392082 HAS BEEN RAISED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    ON (B)(6) 2017, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT EC8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT RESULTS ON A (B)(6) MALE PATIENT ADMITTED TO THE PICU FOR INFANTILE SPASMS. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. THE CUSTOMER STATES THAT RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. LAB ANALYZER MAKE AND MODEL # ARE UNKNOWN. THE CUSTOMER STATES THAT THE WAS NO HARM TO THE PATIENT, PATIENT WAS TREATED ON THE LAB ANALYZER RESULT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. DATE: (B)(6) 2017, TIME: 1003, METHOD: I-STAT, RESULT: 8.0. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. THE INVESTIGATION IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531789 I-STAT EC8+ CARTRIDGE EC8+ CARTRIDGE CHL ABBOTT POINT OF CARE NA K16342 10054749002266

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO