BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMAL ANALYZER

    MDR report key: 1820913 · Received August 26, 2010

    Report

    Report Number
    2245578-2010-00083
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Date of Event
    April 1, 2005
    Report Date
    August 25, 2010
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LATE MDR IS A RETROSPECTIVE FILING. THE RETROSPECTIVE FILING IS IN RESPONSE TO ABBOTT POINT OF CARE INC., (B)(4). FDA INSPECTION CONDUCTED JULY 2010. THE I-STAT PORTABLE CLINICAL ANALYZER AND THE I-STAT 1 ANALYZER OPERATE ON 9 VOLT BATTERIES. ACROSS THESE BATTERIES AND AT OTHER NODES CONNECTING TO THESE BATTERIES, A NUMBER OF TANTALUM CAPACITORS EXIST IN THE CIRCUITRY. SHOULD THE CAPACITORS EXPERIENCE A RELIABILITY FAILURE, A LOW INTERNAL IMPEDANCE PATH MAY FORM IN THE CAPACITOR RESULTING IN EXCESSIVE POWER DISSIPATION IN THE COMPONENT AS THE BATTERY IS EFFECTIVELY SHORT CIRCUITED. THERE ARE 4 OF THESE CAPACITORS IN EACH ANALYZER MODEL THAT CONNECT DIRECTLY TO THE BATTERIES. FOR THE I-STAT 1, THE REFERENCE DESIGNATORS FOR THE COMPONENTS ARE C4, C13, C26 AND C21. FOR THE I-STAT PORTABLE CLINICAL ANALYZER, THE REFERENCE DESIGNATORS ARE C169, C176, C180 AND C186. IN ADDITION, IT HAS BEEN DETERMINED DEFECTIVE BATTERY CARRIERS AND FLEX CABLES MAY ALSO CAUSE THE BATTERIES TO BE SHORT CIRCUITED. (B)(4).

    Description of Event or Problem · 1

    THIS LATE MDR IS A RETROSPECTIVE FILING. ON (B)(6) 2005, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED THE I-STAT 1 ANALYZER WAS HOT TO TOUCH. BASED ON THE INFO AT THE TIME, THERE WAS NO INJURY ASSOCIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMAL ANALYZER THERMAL ANALYZER JJE ABBOTT POINT OF CARE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1