BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT ACT CELITE CARTRIDGE

    MDR report key: 2862466 · Received December 10, 2012

    Report

    Report Number
    2245578-2012-00401
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JBP
    PMA / PMN Number
    K992571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION WAS COMPLETED ON 01/10/2013. NO DEFICIENCY WAS IDENTIFIED AND THE CARTRIDGES ARE FUNCTIONING ACCORDING TO SPECIFICATION.

    Additional Manufacturer Narrative · 1

    APOC INCIDENT #(B)(6).

    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 A DISCREPANT RESULT OF 529 ON A PATIENT. DATE (B)(6) 2012: 1800, WARFARIN SODIUM, 5 MG PER ORAL. 1800, INSULIN, SC SLIDING SCALE. EVENT DATE: (B)(6) 2012: TIME: MEDICATION: DOSAGE: I-STAT: COMMENT: 0946, 114, BASELINE. 0958, HEPARIN DSR IV, 3000 UNITS. 1000, HEPARIN DSR IV, 2000 UNITS. 1001, HEPARIN DSR IV, 3000 UNITS. 1003, HEPARIN DSR IV, 2200 UNITS, P/HR (44ML/HR). 1020 HEPARIN DSR IV 3000 UNITS 1021, 206. 1037, 206. 1045, 206. 1054, 210. 1120, 287. 1148, - DISCONTINUED. 1158, 275. 1411, *179. 1517, *529. 30 MIN LATER, *149. *SALINE IS RUNNING ON THE LINE BEFORE DRAW, DC AND 10 CC WASTE FROM SHEATH AND THEN PULL THE BLOOD (PLAIN SYRINGE). CUSTOMER STATES THAT THE SAME NURSE RAN ALL THREE DRAWS AND NO HEPARIN WAS ADMINISTERED DURING THE TIME FROM THE FIRST DRAW AND THE SYRINGES HAVE BEEN CONFIRMED THAT THEY ARE PLAIN SYRINGES WITH NO ADDITIVE. BASED ON THE INFORMATION AT THIS TIME THERE WERE NO INJURIES REPORTED. BASED ON THE INFORMATION AVAILABLE THERE IS NO REASON TO BELIEVE A MALFUNCTION EXISTS. RETAINS TESTING IS COMPLETE AND THERE WERE NO DEFICIENCIES. THE COMPLETE INVESTIGATION IS PENDING. THERE IS REASON TO BELIEVE THAT THE RESULT OF 529 AT 15:17 MAY HAVE BEEN CONTAMINATED; HOWEVER, THIS IS NOT CONFIRMED AT THIS TIME.

    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 S12243

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Congenital Anomaly