BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUCOSTABILIZER

    MDR report key: 10856065 · Received November 17, 2020

    Report

    Report Number
    3010817588-2020-00001
    Event Type
    Injury
    Date Received
    November 17, 2020
    Date of Event
    September 30, 2020
    Report Date
    November 4, 2020
    Manufacturer
    MEDICAL DECISION NETWORK
    Product Code
    NDC
    PMA / PMN Number
    K141321
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MDN WAS WORKING TO SET UP OUT PRODCITION ACCOUNT; THIS IS OUR FIRST ELECTRONIC REPORT AND WAS DELAYED DUE TO THE SIGNUP PROCESS. (B)(6).

    Description of Event or Problem · 1

    SK ALLEGED THAT SHE WAS IN MOSES H CONE HOSPITAL AS A PATIENT FROM (B)(6) THROUGH (B)(6) 2020. SHE STATED SHE HAS TYPE 1 DIABETES AND WAS ON GLUCOSTABILIZER DURING HER STAY AND THAT SHE WENT INTO DIABETIC KETOACIDOSIS (DKA) 2 TIMES. INITIAL INVESTIGATION SHOWED THAT GLUCOSTABILIZER DID NOT MALFUNCTION; THE MULTIPLIER AND CALCULATED INSULIN INFUSION RATES PERFORMED PER THE ALGORITHM AND THE CONFIGURED SETTINGS BY MOSES CONE. ALL CONFIGURATION SETTINGS APPEARED APPROPRIATE. THE GLUCOSE ENTRIES APPEARED TIMELY. THE BLOOD GLUCOSE VALUES ENTERED INTO GLUCOSTABILIZER FOR SK WERE NOT TYPICAL FOR DKA, HOWEVER EUGLYCEMIC (NEAR NORMAL OR MILDLY ELEVATED BLOOD GLUCOSE LEVELS) DKA CAN OCCUR. AFTER SPEAKING WITH THE CLIENT, MOSES CONE, IT WAS LEARNED THAT SK WAS HOSPITALIZED WITH A DIAGNOSIS OF DKA AND PRIOR TO THE DKA ADMISSION SK MEDICATION REGIMEN INCLUDED A SODIUM-GLUCOSE COTRANSPORTER (SGLT) INHIBITOR

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322639 GLUCOSTABILIZER CALCULATOR, DRUG DOSE NDC MEDICAL DECISION NETWORK V3.5 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other