BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT ACT CELITE CARTRIDGE

    MDR report key: 2821469 · Received November 6, 2012

    Report

    Report Number
    2245578-2012-00395
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 16, 2012
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JBP
    PMA / PMN Number
    K992571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION WAS COMPLETED ON (B)(4) 2012. NO DEFICIENCY WAS IDENTIFIED AND THE CARTRIDGES ARE FUNCTIONING ACCORDING TO SPECIFICATION.

    Description of Event or Problem · 1

    ON (B)(6) 2012, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING ACT CELITE CARTRIDGES THAT YIELDED DISCREPANT RESULTS. ON A PATIENT WITH DIAGNOSIS OF HEMATOCHEZIA DISEASE.* DENOTES RESULT(S) THE CUSTOMER IS QUESTIONING.PATIENT HAD A TOTAL OF 14 RESULTS ON (B)(6) 2012 DURING SURGERY:TIME RESULT1:09 PM 287 SEC1:32 PM 295 SEC1:42 PM 229 SEC1: 53PM 452 SEC *2:00 PM >1000 SEC*2:06 PM >1000 SEC* 2:29 PM 302 SEC2:29 PM 260 SEC 2:49 PM 272 SEC2:49 PM 310 SEC3:19 PM 287 SEC3:21 PM 348 SEC3:49 PM 195 SEC3:49 PM 199 SECBASED ON THE INFORMATION AT THIS TIME THERE WERE NO INJURIES REPORTED. CUSTOMER HAS NOT PROVIDED TIMES OR AMOUNTS OF HEPARIN GIVEN TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT ACT CELITE CARTRIDGE ACT CELITE CARTRIDGE JBP ABBOTT POINT OF CARE NA T12202

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Congenital Anomaly