BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT ACT CELITE CARTRIDGE

    MDR report key: 2386119 · Received November 17, 2011

    Report

    Report Number
    2245578-2011-00359
    Event Type
    Malfunction
    Date Received
    November 17, 2011
    Date of Event
    September 21, 2011
    Report Date
    October 27, 2011
    Manufacturer
    ABBOTT POINT OF CARE, INC.
    Product Code
    JBP
    PMA / PMN Number
    K992571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOT: S11154, MANUFACTURED: 06/2011; EXPIRATION: 11/28/2011.

    Description of Event or Problem · 1

    ON (B)(6) 2011, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT ACT CELITE CARTRIDGES THAT YIELDED A DISCREPANT RESULT ON A PT. CUSTOMER USED TWO DIFFERENT LOTS. (B)(6) 2011: I-STAT ACT 177 AT 0846 (LOT S11196B), I-STAT ACT 181 AT 0901 (LOT S11196B), I-STAT ACT 188 AT 0901 (LOT S11154), I-STAT ACT 195 AT 1022 (LOT S11196B); I-STAT ACT 170 AT 0953 (LOT S11196B). BASED ON THE INFORMATION AVAILABLE AT THE TIME, THERE WERE NO INJURIES ASSOCIATED WITH THIS EVENT. NEW INFORMATION WAS RECEIVED (B)(6) 2011 STATING THAT THERE WAS NO IMPACT TO THE PT AND THERE WAS NO DELAY. HOWEVER, IT IS NOT CLEAR IF PT MANAGEMENT WAS IMPACTED. THE INVESTIGATION WAS COMPLETED ON (B)(6) 2011. FINISH GOODS AND RETAIN TESTING SHOWED THAT LOTS S11196B AND S11154 ARE PERFORMING TO SPECIFICATION. (B)(6) 2011 SUGGESTED THAT PT MANAGEMENT MAY HAVE BEEN IMPACTED DUE TO THE AMOUNT OF HEPARIN AND PROTAMINE ADMINISTERED TO PT. THOUGH THIS IS UNKNOWN BASED ON THE INFORMATION AVAILABLE; 5000 UNITS OF HEPARIN AT 08:30, ACT AT 08:46 - 177; 2000 UNITS OF HEPARIN AT 08:51, ACT AT 09:01 - 1181; 3000 UNITS OF HEPARIN AT 09:06, 50 NG OF PROTAMINE AT 09:30; 7000 UNITS OF HEPARIN AT 09:44, ACT AT 09:53 - 170; 4000 UNITS OF HEPARIN AT 09:57, ACT AT 10:03 TEST CANCELED BY OPERATOR AT 800 SEC. METER DISPLAYED 0. ACT AT 10:22 - 195; 50 NG PROTAMINE AT 10:30 OR 10:40.

    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, INC. NA S11196B

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR