BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDUO

    MDR report key: 719654 · Received May 25, 2006

    Report

    Report Number
    9681821-2006-00040
    Event Type
    Injury
    Date Received
    May 25, 2006
    Date of Event
    April 1, 2006
    Report Date
    April 26, 2006
    Manufacturer
    NOVO NORDISK A/S, MEDICAL SYSTEMS
    Product Code
    KZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LOW BLOOD SUGARS WITH LOSS OF CONSCIOUSNESS [HYPOGLYCAEMIC COMA] CASE DESCRIPTION: THIS SPONTANEOUS CASE, REPORTED BY A CONSUMER FROM THE UNITED STATES AS "LOW BLOOD SUGAR WITH LOSS OF CONSCIOUSNESS", CONCERNS A MALE WHO WAS USING AN INDUO INSULIN DOSER FROM 02 TO PRESENT, NOVOLOG PENFILL AND OTHER SUSPECT PRODUCT SYMILIN (PRAMLINITIDE, CODED "ANTI-DIABETIC") FROM 4/06 TO ONGOING FOR TYPE II DIABETES MELLITUS. MEDICAL HISTORY INCLUDED HYPERTENSION, DEPRESSION, HYPOTHYROIDISM, JOINT PAIN AND BONE DENSITY LOSS. IN 4/06, THE DEVICE IN QUESTION FAILED A FUNCTION CHECK AND TOO MUCH INSULIN WAS DISPENSED. EARLY THAT SAME EVENING, AFTER THE DEVICE HAD FAILED THE FUNCTION CHECK, THE MAN EXPERIENCED LOW BLOOD SUGAR OF 25 MG/DL WITH LOSS OF CONSCIOUSNESS (REPORTED IN CASE # 252722). SOMETIME AFTER THE FIRST EPISODE (DATE UNK), WHILE STILL USING THE SAME DEVICE, THE MAN TRIED TO GET UP FROM HIS CHAIR AND FELL TO THE FLOOR. HIS WIFE ADMINISTERED A SUBCUTANEOUS INJECTION OF GLUCAGON (DOSE UNK) AND THE MAN AWOKE WITHIN A FEW MINUTES. HE DID NOT INCUR ANY INJURIES DURING HIS FALL. THE MAN STATED THAT HE WAS UNABLE TO RECALL ANY FURTHER DETAILS OF HIS TREATMENT AND HAD NO MEMORY OF THE EVENT. THE PT THEN SWITCHED TO A NEW INDUO AND HAS NOT EXPERIENCED LOW BLOOD SUGAR LEVELS SINCE THAT TIME. THE MAN REPORTED THAT HE ALSO SUSPECTED THAT SYMLIN, WHICH HE STARTED ON 4/3/06, CONTRIBUTED TO HIS LOW BLOOD SUGAR WITH LOSS OF CONSCIOUSNESS. HE WAS ALSO DIAGNOSED WITH HIGH BLOOD PRESSURE IN 4/06 AND INITIATED THERAPY WITH ALTACE (RAMIPRIL) AROUND THE SAME TIME OF THE EVENT. IN 4/06, HE WAS SEEN BY HIS PHYSICIAN AND HIS DAILY DOSAGE OF NOVOLOG INSULIN WAS DECREASED FROM 40 UNITS ADMINISTERED IN SEVEN INJECTIONS TO 23 UNITS ADMINISTERED IN 3 INJECTIONS. HE HAS NO RENAL OR HEPATIC DISORDERS, BUT HE DID REPORT THAT HE WAS A BRITTLE DIABETIC. REPORTEDLY, THE PT RECOVERED COMPLETELY. ANALYSIS RESULTS: PRODUCT: INNOVO FOR INDUO LOT NO: LW40142 DEVICE CONCLUSION: TECHNICAL EXAMINATION WERE PERFORMED. CASE CONCLUSION: THE MOVEMENT ACCURACY OF THE PISTON ROD WAS MEASURED. THE RESULT WAS WITHIN ACCEPTABLE LIMITS. THE OBSERVED PROBLEM WITH THE RUBBER SEAL IS DUE TO A MOULDING FAULT. THE PROBLEM WITH THE RUBBER ON THE DOSE SELECTOR IS DUE TO A DESIGN WEAKNESS. NOTE: THIS PT EXPERIENCED A SIMILAR EVENT WITH THE SAME DEVICE, WHICH HAS BEEN REPORTED UNDER MFR. REP. # 9681821-06-00039 (PT ID 252722) COMMENT: REPORTER CAUSALITY: UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDUO INSULIN DELIVERY DEVICE KZE NOVO NORDISK A/S, MEDICAL SYSTEMS NA LW40142

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening| R