BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CHEM8+ CARTRIDGE

    MDR report key: 2222924 · Received July 15, 2011

    Report

    Report Number
    2245578-2011-00116
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    April 14, 2011
    Report Date
    July 15, 2011
    Manufacturer
    ABBOTT POINT OF CARE CANADA LTD
    Product Code
    MZV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011 ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED DISCREPANT RESULTS FOR SODIUM (NA) AND HEMATOCRIT (HCT) BETWEEN THE I-STAT AND THEIR LAB INSTRUMENT ON A PT WHO WAS TAKEN TO PRE-CATH TESTING. I-STAT RESULT: 7:01 AM, NA = 111 MMOL/L, HCT = 23 %PCV; LAB RESULT: 10:17 AM, NA = 137 MMOL/L, HCT = 33 %PCV. BASED ON THE INFO AT THE TIME, THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT AND NO EVIDENCE OF A PRODUCT PROBLEM. INTERNAL COMPLAINT INVESTIGATION WAS COMPLETED ON (B)(4) 2011 AND IT WAS DETERMINED THROUGH RETURN CARTRIDGE TESTING AND VISUAL INSPECTION THAT A SECTION OF CHEM8+ LOT C10353 HAS MISSING NA+ MEMBRANES/DAMAGED NA+ SENSOR CAUSING NA+, CI- AND HCT UNEXPECTED RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT CHEM8+ CARTRIDGE CHEM8+ CARTRIDGE MZV ABBOTT POINT OF CARE CANADA LTD NA C10353

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK