BEUDAMED
    FDA Adverse Event Injury Summary report: N

    H-TRONPLUS

    MDR report key: 1013663 · Received March 14, 2008

    Report

    Report Number
    2183996-2008-00353
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    March 6, 2008
    Report Date
    March 6, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K023471
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE PATIENT'S HUSBAND REPORTED THE PATIENT EXPERIENCED AN "INSULIN REACTION" IN 2008. HE STATED HE PUT SOME "GLUCOSE" IN HER MOUTH AND HAD HER SIP SOME ORANGE JUICE. HE STATED SHE WAS DOING BETTER BUT SHE REFUSED TO EAT SO HE DROVE HER TO THE EMERGENCY ROOM. HE STATED HER BLOOD GLUCOSE LEVEL WHEN SHE ARRIVED AT THE HOSPITAL WAS 170 MG/DL WITH HER NORMAL READING BEING 120 MG/DL. HE STATED HER DOCTOR WAS NOT CONCERNED BY THAT READING. HE SAID THE PATIENT WAS KEPT IN THE EMERGENCY ROOM WITH HER INSULIN INFUSION DEVICE ON AND WAS RELEASED AFTER SHE WAS THERE FOR "ABOUT HALF A DAY." THE PATIENT'S HUSBAND STATED THE HOSPITAL THOUGHT THE INCIDENT WAS RELATED TO HER BLOOD GLUCOSE LEVELS. HE SAID, HE BELIEVES THE INCIDENT IS NOT PRODUCT RELATED, BUT IS DUE TO THE FACT THAT THE PATIENT HAS BEEN REFUSING TO EAT AND HE DOES NOT KNOW HOW TO GET HER TO EAT. HE STATED SHE WOKE UP VOMITING BUT THOUGHT THAT MIGHT BE DUE TO THE PAIN PILLS SHE IS ON. HE STATED THE PATIENT WOULD NOT LET HIM NEAR HER INSULIN INFUSION DEVICE. DUE TO THIS AND THE INABILITY OF THE COMPANY REPRESENTATIVE TO SPEAK TO THE PATIENT, NO TROUBLESHOOTING COULD BE DONE. NO PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 H-TRONPLUS INSULIN INFUSION PUMP LZG DISETRONIC MEDICAL SYSTEMS H-TRONPLUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R INSULIN INFUSION SET| INSULIN