BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT EC8+ CARTRIDGE

    MDR report key: 8435836 · Received March 20, 2019

    Report

    Report Number
    2245578-2019-00064
    Event Type
    Malfunction
    Date Received
    March 20, 2019
    Date of Event
    December 1, 2018
    Report Date
    May 7, 2019
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    CHL
    UDI-DI
    10054749000057
    PMA / PMN Number
    K940918
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT #: (B)(4). THE INVESTIGATION WAS COMPLETED ON 04/23/2019. THE LOT NUMBER WAS NOT PROVIDED. A REVIEW OF SHIPPING RECORDS DETERMINED THAT THE CUSTOMER WOULD HAVE HAD EC8+ LOT K18341 AT THE TIME OF INCIDENT; THEREFORE, THIS LOT WAS USED FOR INVESTIGATION. ON 04/04/2019 NEW INFORMATION WAS RECEIVED. THE CUSTOMER CONFIRMED THAT LOT K18341 WAS USED DURING THE EVENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THE CARTRIDGE LOT MET FINISHED GOODS (FG) RELEASE CRITERIA. RETAINED TESTING MET THE ACCEPTANCE CRITERIA OUTLINED IN APPENDIX 1 OF Q04.01.003 REV. AC (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE). NO DEFICIENCY HAS BEEN DETERMINED FOR EC8+ LOT K18341.

    Additional Manufacturer Narrative · 0

    APOC INCIDENT #: (B)(4). FROM: I-STAT EG6+ CARTRIDGE, CATALOG # 03P77-25, LOT: UNK, MFG DATE: UNK, EXP DATE: UNK, UDI: (B)(4). TO: I-STAT EC8+ CARTRIDGE, CATALOG # 03P79-25, LOT: K18341, MFG DATE: 12/07/2018, EXP DATE: 07/08/2019, UDI: (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2019, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT EG6+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT POTASSIUM RESULT OF 6.0 ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. (B)(6). AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXIST. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE PATIENT WAS TESTED IN (B)(6) OF 2018 BUT THE ACTUAL DAY IS UNKNOWN. THE CUSTOMER PROVIDED TWO I-STAT RESULTS NO PATIENT INFORMATION, SAMPLE AND COLLECTION TIMES WITH MULTIPLE ATTEMPTS TO OBTAIN INFORMATION. CARTRIDGE LOT IS UNKNOWN AT THIS TIME AND COULD POTENTIALLY RENDER THE INVESTIGATION INCONCLUSIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229747 I-STAT EC8+ CARTRIDGE EC8+ CARTRIDGE, PRODUCT CODE: CHL CHL ABBOTT POINT OF CARE NA K18341 10054749000057

    Patients

    Seq Age Sex Outcome Treatment
    1