BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT1 ANALYZER, IMMUNO READY

    MDR report key: 18836633 · Received March 5, 2024

    Report

    Report Number
    2245578-2024-00050
    Event Type
    Malfunction
    Date Received
    March 5, 2024
    Date of Event
    February 22, 2024
    Report Date
    May 14, 2024
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    CGA
    PMA / PMN Number
    K103195
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: (B)(4) THE INVESTIGATION WAS COMPLETED ON 08-MAY-2024. THE CUSTOMER REPORTED THAT ANALYZER S/N (B)(6) GENERATED QUALITY CHECK CODE (QCC) 43 WHEN TESTING CARTRIDGES. THE CUSTOMER ALSO STATED THAT THE KEYS WERE NOT RESPONDING. THE ANALYZER WAS RETURNED FOR REPAIR AND THE DISTRIBUTOR REPAIR CENTER (DRC) REPORTED COSMETIC DAMAGE AND MULTIPLE BURNED COMPONENTS WERE NOTED. THE DRC ALSO REPORTED THAT QCC 66 WAS OBSERVED DURING FAILURE ANALYSIS. FAILURE ANALYSIS CONFIRMED THE COMPLAINT OF THE UNRESPONSIVE KEYPAD UPON RECEIPT (DETERMINED TO BE CAUSED BY THE MELTED KEYPAD BEZEL). QCC 43 COULD NEITHER BE CONFIRMED VIA THE ANALYZER MEMORY (FAILED TO TRANSMIT) NOR REPRODUCED (UNABLE TO PERFORM TESTING). VISUAL INSPECTION OBSERVED MULTIPLE BURNED COMPONENTS WHICH PREVENTED FURTHER FAILURE ANALYSIS ESPECIALLY ON THE MAIN PCB. PER THE INCIDENT SUMMARY, THE CUSTOMER REPORTED PLACING THE ANALYZER ON A BABY WARMER IN AN ATTEMPT TO RESOLVE QCC 43. ADDITIONALLY, THE CUSTOMER WAS USING 9 VOLT DURACELL ALKALINE BATTERIES INSTEAD OF 9-VOLT LITHIUM BATTERIES (APOC LIST NUMBER: 06F21-26) THAT ARE RECOMMENDED PER ART: 714364-00Y, OF THE I-STAT SYSTEM MANUAL [REF. 2] THE 9-VOLT LITHIUM BATTERIES HAVE A SAFETY FEATURE THAT PROVIDES PROTECTION PREVENTING THE I-STAT 1 ANALYZER FROM OVERHEATING DUE TO COMPONENT FAILURE WITHIN THE ANALYZER CIRCUITRY. A ROCKET WARE SEARCH SPANNING THREE MONTHS REVEALED NO SIMILAR INCIDENTS. NO DEFICIENCY HAS BEEN IDENTIFIED.

    Description of Event or Problem · 0

    ON (B)(6) 2024, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT I-STAT 1 ANALYZER SN (B)(6) YIELDED QUALITY CHECK CODE 43 WHILE RUNNING CARTRIDGE TEST. THE CUSTOMER ALSO STATED THAT THE KEYS WERE NOT RESPONDING. THERE WERE NO OTHER REPORTS FROM THE CUSTOMER/USER. THE ANALYZER WAS RETURNED FOR REPAIR AND ON (B)(6) 2024, DURING REPAIR ANALYSIS, SOME OF THE INTER COMPONENTS WERE FOUND BURN AND THE ANALYZER WOULD NOT ACTIVATE. THE REPAIR SITE PRESENTED PICTURES OF THE COMPONENTS THAT WERE FOUND CHARRED/BURNT AND MELTED BARCODE SCANNER. PICTURES OF THE BATTERIES USED WERE NOT PROVIDED BUT REQUESTED. COSMETIC DAMAGE WAS ALSO NOTED ON THE ANALYZER. APOC HAS DETERMINED THAT A COMPONENT FAILURE WITHIN THE ANALYZER CIRCUITRY, MAY LEAD TO THE BATTERIES BECOMING UNCOMFORTABLY HOT TO TOUCH IN THE AREA OF THE BATTERY COMPARTMENT WHEN USING A GREEN NON-FUSED BATTERY CARRIER. THERE ARE NO INJURIES ASSOCIATED WITH THE EVENTS. THE PRODUCT WAS REPLACED AND RETURNED FOR INVESTIGATION. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO PATIENT OR USER RELATED INJURIES ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1882144 I-STAT1 ANALYZER, IMMUNO READY I-STAT1 ANALYZER CGA ABBOTT POINT OF CARE NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown