BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT EC8+ CARTRIDGE

    MDR report key: 6932290 · Received October 9, 2017

    Report

    Report Number
    2245578-2017-00336
    Event Type
    Malfunction
    Date Received
    October 9, 2017
    Date of Event
    April 15, 2016
    Report Date
    October 9, 2017
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    CHL
    UDI-DI
    10054749000071
    PMA / PMN Number
    K940918
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    APOC INCIDENT # (B)(4). APOC LABELING WAS EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT. THE INVESTIGATION WAS COMPLETED ON 09/07/2016. RETAIN PRODUCT WAS TESTED AND FUNCTIONING ACCORDING TO SPECIFICATION. RETURN PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION. INVESTIGATION: THE CUSTOMER REPORTED OBTAINING UNEXPECTED NA+ AND K+ RESULTS WHILE USING EC8+ CARTRIDGE LOT K15324 TO TEST A PATIENT SAMPLE. THE DEVICE HISTORY RECORD FOR THIS LOT WAS REVIEWED. THE LOT PASSED FINISHED GOODS RELEASE CRITERIA. EC8+ LOT K15324 EXPIRED (14-JUN-16) BEFORE RETAIN CARTRIDGE TESTING COULD BE PERFORMED. AS OF 01-SEP-16, 18,900 CARTRIDGES FROM LOT K15324 HAVE BEEN DISTRIBUTED. NO OTHER SITE HAS REPORTED OBSERVING DISCREPANT NA+ OR K+ RESULTS. NO DEFICIENCY HAS BEEN IDENTIFIED. ASSESSMENT: THE COMPLAINT INVESTIGATION CONCLUDED THERE WAS NO PRODUCT DEFICIENCY AND THAT THE I-STAT CARTRIDGE LOT IS MEETING SPECIFICATION.

    Description of Event or Problem · 1

    ON (B)(6) 2016, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT EC8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT SODIUM AND POTASSIUM RESULTS ON A PATIENT (DOG). THE CUSTOMER STATED THAT THE PATIENT PASSED AWAY AT A LATER DATE BEFORE RETESTING. THE CAUSE OF DEATH IS UNKNOWN. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. DATE: TIME: METHOD: NA+ RESULT MEQ/L: K+ RESULT MEQ/L: SAMPLE: (B)(6) 2016, 10:16AM, I-STAT, 118 MEQ/L, > 9MEQ/L , A. (B)(6) 2016, 11:15AM, VS2, UNREADABLE, 3.7 MEQ/L, B. AT THE TIME OF THE EVENT THERE WAS NO INDICATION OF A PRODUCT MALFUNCTION BASED ON THE INFORMATION PROVIDED AND ASSESSED BY APOC, HOWEVER THIS MDR IS A RETROSPECTIVE FILING IN RESPONSE TO AN OBSERVATION FROM AN FDA INSPECTION CONDUCTED MAY 8TH TO 12TH, 2017 AT ABBOTT POINT OF CARE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712863 I-STAT EC8+ CARTRIDGE EC8+ CARTRIDGE CHL ABBOTT POINT OF CARE NA K15324 10054749000071

    Patients

    Seq Age Sex Outcome Treatment
    1