BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYSMEX UF-1000I

    MDR report key: 3772610 · Received March 18, 2014

    Report

    Report Number
    3009711478-2014-00006
    Event Type
    Other
    Date Received
    March 18, 2014
    Date of Event
    February 4, 2014
    Report Date
    February 27, 2014
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    GKP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    NO EVIDENCE WAS PROVIDED TO SUPPORT THAT AN ACTUAL DEVICE FAILURE OCCURRED OR THAT THE DEVICE FAILED TO PERFORM WITHIN SPECS. ANALYZER PRINTOUTS WOULD DEMONSTRATE THE ANALYZER'S FINDINGS WITH THIS SAMPLE. THE USER'S INSTRUCTION WAS CONTACTED BY MULTIPLE INDIVIDUALS FROM SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, WHICH SELLS AND SERVICES THESE ANALYZERS IN THE US, TO OBTAIN THE PRINTOUTS, HOWEVER, THE USER AND THE ATTORNEY WERE UNWILLING TO PROVIDE THESE. THE ATTORNEY STATED THAT THESE RESULTS WERE REPORTED BY MISTAKE.

    Description of Event or Problem · 1

    A (B)(6) Y/O PT TO THE EMERGENCY DEPARTMENT OF (B)(6) HOSPITAL COMPLAINING OF ABDOMINAL PAIN, VOMITING AND FEVER. THE ATTENDING PHYSICIAN ORDERED A URINALYSIS TO CONFIRM / REFUTE A DIAGNOSIS OF URINARY TRACT INFECTION. THE OPERATOR OF THE UF-1000; FULLY AUTOMATED URINE PARTICLE ANALYZER RAN THIS PT'S SAMPLE ON THE ANALYZER. THE ATTORNEY FOR THE FACILITY STATED THAT THE LAB TECH ACCIDENTALLY INCLUDED THAT SPERMATOZOA WAS PRESENT ON THE PT'S REPORT. SPERM IS A FLAGGED CONSISTENT ON THE PT'S REPORT. SPERM IS A FLAGGED CONSTITUENT ON THE ANALYZER; FLAGS ARE MEANT TO ALERT THE OPERATOR TO SAMPLE ABNORMALITY REQUIRING VERIFICATION PRIOR TO REPORTING. THE TECH MISSED THE FLAG AND SPERMATOZOA WAS REPORTED. THE RESULT LATER WAS DETERMINED TO BE A FALSE POSITIVE. THE FACILITY'S CHILD SEXUAL ABUSE PROTOCOL WAS TRIGGERED GIVEN THE CHILD'S AGE. LOCAL POLICE AND CHILD PROTECTIVE SERVICES WERE CONTACTED. THE CHILD WAS TRANSFERRED TO ANOTHER FACILITY FOR AN UNNECESSARY EXAMINATION WITH A DIAGNOSIS OF SUSPECTED ABUSE OF A CHILD. INVESTIGATIONS TYPICALLY INCLUDE EXAMINATION OF GENITALIA AND COLLECTIONS OF SWABS FOR CULTURE AND PRESENCE OF FOREIGN DNA. SUCH INVASIVE EXAMINATION MAY BE MENTALLY AND EMOTIONALLY DAMAGING TO A PT OF THIS AGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161171 SYSMEX UF-1000I FULLY AUTOMATED URINE PARTICLE ANALYZER GKP SYSMEX CORPORATION UF-10001

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other