BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2245578-2017-00037

    MDR report key: 6736996 · Received July 24, 2017

    Report

    Report Number
    2245578-2017-00037
    Event Type
    Malfunction
    Date Received
    July 24, 2017
    Date of Event
    June 28, 2017
    Report Date
    September 28, 2017
    PMA / PMN Number
    K053110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.

    Additional Manufacturer Narrative · 1

    APOC INCIDENT # (B)(4). THE INVESTIGATION WAS COMPLETED ON 09/22/2017. RETAIN PRODUCT WAS TESTED AND THE CUSTOMER'S COMPLAINT WAS NOT REPRODUCED. RETURN PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6)2017, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT HEMATOCRIT RESULT ON A PATIENT PRESENTED WITH JAUNDICE/ ALTERED MENTAL STATUS AND WEAKNESS. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. THE CUSTOMER STATES THAT PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD: SAMPLE: DATE: COLLECTION: TEST : RESULT: I-STAT, A-WB, (B)(6)2017, 1822, 1828, HCT 38 / HB 12.9. BECKMAN, B-WB, (B)(6)2017, 1822, 1828, HCT 18.7 / HB 5.8. I-STA,T A-WB, (B)(6)2017, 1822, 1850, HCT 24 / HB 8.2. ON (B)(6)2017 AT 08:05, THE PATIENT RECEIVED A BLOOD TRANSFUSION OF FRESH FROZEN PLASMA , 1 UNIT EACH TIME BASED ON THE LAB RESULT. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. THE INVESTIGATION IS UNDERWAY.

    Description of Event or Problem · 1

    NA.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR