BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT EC8+ CARTRIDGE

    MDR report key: 6752562 · Received July 28, 2017

    Report

    Report Number
    2245578-2017-00077
    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 PRESENTED IN THE ED ON A DIABETIC EMERGENCY. THE PATIENT WAS TREATED AND DISCHARGED. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. 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: 1635, METHOD: I-STAT, RESULT: 7.1; (B)(6) 2017 1705, LAB, 2.8. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. THE INVESTIGATION IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531790 I-STAT EC8+ CARTRIDGE EC8+ CARTRIDGE CHL ABBOTT POINT OF CARE NA K16342 10054749002266

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR