BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVOPEN 1.5

    MDR report key: 43075 · Received September 30, 1996

    Report

    Report Number
    9681821-1996-00002
    Event Type
    Other
    Date Received
    September 30, 1996
    Date of Event
    September 6, 1906
    Report Date
    September 30, 1996
    Manufacturer
    NOVO NORDISK A/S
    Product Code
    KZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    OVERDOSE: A WOMAN REPORTED THAT SHE REC'D AN OVERDOSE OF INSULIN WITH HER FIRST INJECTION OF NOVOLIN N (RDNA) PENFILL INSULIN IN A 1.5 DEVICE. THE WOMAN FELT THAT THE DEVICE OVER DELIVERED THE DOSE OF INSULIN. SHE STATED THAT SHE WENT TO THE ER FOLLOWING THE INJECTION BUT SHE DID NOT REMEMBER EXPERIENCING ANY SYMPTOMS. THE WOMAN DENIED ANY LOSS OF CONSCIOUSNESS BUT REPORTED THAT THE WOMAN PRESENTED TO THE ER WITH THE COMPLAINT THAT SHE THOUGHT SHE ACCIDENTALLY REC'D 80 UNITS OF INSULIN WHEN SHE NORMALLY TAKES HALF THAT AMOUNT. SHE WAS ADMITTED FOR OBSERVATION AND OVER THE 24 HOUR HOURS THAT SHE WAS OBSERVED SHE HAD. NO SIGNIFICANT HYPOGLYCEMIA DEVELOPED. HE CONCLUDED THAT THERE WAS NO UNDUE HARM CAUSED TO THE WOMAN BY THE EVENT. THE WOMAN HAS NOT RETURNED THE DEVICE TO FOR EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVOPEN 1.5 INSULIN DELIVERY DEVICE KZE NOVO NORDISK A/S NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization CONCOMITANT DRUGS STRENGTH FROM TO BUMEX