BEUDAMED
    FDA Adverse Event Injury Summary report: N

    D-TRONPLUS

    MDR report key: 809690 · Received January 24, 2007

    Report

    Report Number
    2183996-2007-00057
    Event Type
    Injury
    Date Received
    January 24, 2007
    Date of Event
    January 1, 2007
    Report Date
    January 14, 2007
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K022831
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    THE PT STATED THE HE HAS HAD PROBLEMS WITH LOW BLOOD GLUCOSE OVER THE LAST COUPLE OF WEEKS. HE STATED HE HAD SOME HIGHS AS WELL, BUT HE FELT THOSE WERE "REBOUNDS" FROM THE TREATMENT OF THE LOWS. HE STATED HIS BLOOD GLUCOSE HAS RANGED FROM 1.7 MMOL/L (30.6 MG/DL) TO 31 MMOL/L (558 MG/DL). HIS NORMAL BLOOD GLUCOSE IS AROUND 9 MMOL/L (162 MG/DL). HE STATED HE DOES NOT HAVE SYMPTOMS WHEN HIS BLOOD GLUCOE IS LOW, BUT HIS WIFE STATES HIS BEHAVIOR CHANGES AND HE IS UNCOOPERATIVE. WHEN HIS BLOOD GLUCOSE IS HIGH, HE FEELS SLUGGISH, THIRSTY, AND HIS MUSCLES FEEL HEAVY. HE STATED THE PARAMEDICS WERE CALLED TWICE LAST WEEK. THE FIRST TIME WAS ON 1/9/07. HE WIFE TRIED TO GIVE HIM JUICE, BUT HE SPIT IT OUT. THE PARAMEDICS TREATED HIM WITH I.V. DEXTROSE 50%. HE DID NOT GO TO THE HOSP. ON 1/12/07, HIS SON FOUND HIM UNCONSCIOUS AND CALLED THE PARAMEDICS. THEY TREATED HIM AGAIN WITH IV DEXTROSE AND HE DID NOT GO TO THE HOSP. HE STATED HE HAS BEEN LETTING HIMSELF RUN HIGH, 10-13 MMOL (180-234 MG/DL). THE PT CHANGES HIS INFUSION TUBING ONCE EVERY 3 WEEKS. THE PT WAS ADVISED TO CONTACT HIS PHYSICIAN. THE PT WAS NOT AVAILABLE FOR FOLLOW UP. NO PRODUCT WILL BE RETURNED FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other| R INSULIN| INSULIN INFUSION SET