BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT 6+ CARTRIDGE

    MDR report key: 8715895 · Received June 20, 2019

    Report

    Report Number
    2245578-2019-00155
    Event Type
    Malfunction
    Date Received
    June 20, 2019
    Date of Event
    April 20, 2019
    Report Date
    July 22, 2019
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JGS
    UDI-DI
    10054749000088
    PMA / PMN Number
    K912387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT # (B)(4). THE INVESTIGATION WAS COMPLETED ON 07/19/2019. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THE LOTS PASSED FINISHED GOODS RELEASE CRITERIA. RETAIN CARTRIDGE TEST RESULTS FROM LOT N19105 MET THE ACCEPTANCE CRITERIA FOUND IN Q04.01.003 REV. AD, APPENDIX 1- PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE. DUE TO THE EXPIRY DATE OF LOT K18209 (24-APR-19) RETAIN TESTING COULD NOT BE PERFORMED. RETAIN CARTRIDGE TEST RESULTS FROM A PREVIOUS INCIDENT FOR LOT K18209 DID NOT MEET THE ACCEPTANCE CRITERION FOR SUPPRESSED RESULTS FOUND IN Q04.01.003 REV. AD, APPENDIX 1- PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATIO,N PROCEDURE. NO DEFICIENCY HAS BEEN IDENTIFIED LOT N19105. A PREVIOUS UNRELATED DEFICIENCY WAS IDENTIFIED FOR HIGHER THAN EXPECTED RATE OF SUPPRESSED RESULTS FOR LOT K18209. QUALITY RECORD 681812 WAS INITIATED TO INVESTIGATE TO ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    APOC INCIDENT # (B)(4). OTHER LOT USED: PRODUCT#: 03P76-25, DESCRIPTION: EG7+, LOT#: N19105, EXPIRATION DATE: 02/13/2019, MFG DATE: 04/15/2019. 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 6+ AND EG7+ CARTRIDGES THAT YIELDED A SUSPECTED A DISCREPANT SODIUM, POTASSIUM, HEMATOCRIT AND HEMOGLOBIN RESULT ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. (B)(6). THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE TESTING BETWEEN EG7+ AND 6+ CARTRIDGES WAS 1 HOUR 2 MINS. THE CUSTOMER WAS ADVISED THAT THE TEST NEEDS TO BE DONE WITHIN 30 MINUTES AFTER COLLECTION FOR NA, K, HCT & HB PER I-STAT SYSTEM MANUAL 714258-01 REV O. IT IS SUSPECTED THAT THE SECOND SAMPLE WAS CLOTTED, AND CAUSE FOR THE CUSTOMER COMPLAINT WAS DUE TO POOR SAMPLE HANDING. THE REPORTING DECISION WAS BASED ON LIMITED 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
    509137 I-STAT 6+ CARTRIDGE 6+ CARTRIDGE JGS ABBOTT POINT OF CARE NA K18209 10054749000088

    Patients

    Seq Age Sex Outcome Treatment
    1