BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT ACT CELITE CARTRIDGE

    MDR report key: 5652747 · Received May 13, 2016

    Report

    Report Number
    2245578-2016-00028
    Event Type
    Malfunction
    Date Received
    May 13, 2016
    Date of Event
    April 13, 2016
    Report Date
    May 20, 2016
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JBP
    PMA / PMN Number
    K992571
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    APOC INCIDENT # (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION WAS COMPLETED ON 05/16/2015. RETAIN PRODUCT WAS TESTED AND IS FUNCTIONING ACCORDING TO SPECIFICATION. RETURN PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2016, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING ACT CELITE CARTRIDGES THAT YIELDED UNEXPECTED RESULTS ON A PATIENT ASSOCIATED WITH LOT# R16004 . THE CUSTOMER STATES THAT THE PHYSICIAN GAVE HEPARIN AS ACT WAS LOW AND THE PATIENT DEVELOPED A BLEED IN THE EYE AND WRIST. PATIENT WAS RE-ASSESSED AND THERE ARE NO APPARENT SIGNS OF PROGRESSION. THE PATIENT'S CURRENT STATE OF CONDITION IS UNKNOWN AT THIS TIME. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. THE FACILITY STATES THAT SAMPLES FOR I-STAT WERE DRAWN AFTER HEPARIN WAS ADMINISTERED. THE FACILITY ALSO STATES THAT RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. SAMPLE TIME: 1743, TEST TIME: 1743, I-STAT RESULT: 193, SAMPLE TYPE: ARTERIAL, HEPARIN TIME: 1743, HEPARIN DOSES: 5000 UNITS, COMMENTS: NO BASELINE TESTING PERFORMED; 1811, 1811, 202, ARTERIAL, 1811, 4000 UNITS, NA; 1830, 1830, 193, ARTERIAL, 1830, 4000 UNITS, NO TESTING PERFORMED BETWEEN 1830 & 1954 HRS; 1954, 1954, >1000, VENOUS, NA, NA, RESULT WAS VERY HIGH AFTER HEPARIN RECEIVED; 2025, 2025, 679, VENOUS, NA, NA, NA; 2108, 2108, 229, VENOUS, NA, NA, NA. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. CUSTOMER STATES THE PATIENT WAS DISCHARGED THE NEXT DAY AFTER THE PROCEDURE. HOWEVER, APOC HAS DETERMINED THAT AN ADVERSE EVENT HAS OCCURED IN THAT THE PATIENT DEVELOPED BLEEDING IN THE EYE AND WRIST BASED ON THE AMOUNT OF HEPARIN ADMINISTERED DURING THE PROCEDURE. THE CUSTOMER STATES THAT NO ACT TESTING WAS PERFORMED FROM 18:30 AND 19:54 DURING THE INTERVENTIONAL AND DIAGNOSTIC PROCEDURE AT THE FACILITY. AT THIS TIME AND BASED ON THE INFORMATION AVAILABLE THERE IS NO REASON TO SUSPECT A MALFUNCTION EXITS. NOR IS THERE REASON TO BELIEVE THAT APOC PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. PRELIMINARY INVESTIGATION ON RETAINS TESTING SHOWS THAT PRODUCT IS PERFORMING TO SPECIFICATION. THE FULL INVESTIGATION IS PENDING.

    Description of Event or Problem · 1

    NA

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309688 I-STAT ACT CELITE CARTRIDGE ACT CELITE CARTRIDGE JBP ABBOTT POINT OF CARE NA R16004

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other