BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMAPEN ERGO 3 ML

    MDR report key: 324709 · Received March 29, 2001

    Report

    Report Number
    1819470-2001-00017
    Event Type
    Injury
    Date Received
    March 29, 2001
    Date of Event
    November 27, 2000
    Report Date
    March 27, 2001
    Manufacturer
    ELI LILLY AND CO
    Product Code
    KZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS CASE REPORTED BY A DIABETOLOGIST CONCERNS A PT. THE PT WAS TREATED FOR TYPE I DIABETES MELLITUS BY HUMAN INSULIN ISOPHANE SUSPENSION (HUMULIN N) AND HUMAN REGULAR INSULIN (HUMULIN R), ADMINISTERED BY HUMAPEN. CONCOMITANT MEDICATIONS WERE PROVIDED AS FOLLOWS: ETOFYLLINE (OXYPHYLLIN), BROMAZEPAM (LEXAURIN) AND PENTOXIFYLLINE (TRENTAL). MEDICAL HISTORY: DIAGNOSED WITH DIABETES MELLITUS TYPE 1 IN 1970. TREATED BY INSULIN INJECTION SINCE 09/1970. FROM 1997 PT USED BD PEN. PT VERY COMPLIANT-REGULAR CHECK-UPS. DIABETES WELL-CONTROLLED, BLOOD GLUCOSE LEVELS STABILISED, WITHOUT HYPO/HYPERGLYCEMIAS. NO DIFFICULTIES USING INSULIN PEN DEVICES IN PAST. THE PT RECEIVED TWO NEW HUMAPENS - FIRST IN 11/2000, THE SECOND 6 DAYS LATER. SEVERAL DAYS LATER, THE REPORTER (PT'S DIABETOLOGIST) WAS CONTACTED BY PT'S FAMILY MEMBER WHO ANNOUNCED, THAT IN 2000 THE PT WAS ADMITTED TO INTENSIVE CARE UNIT OF THE HOSP BECAUSE OF DIABETIC KETOACIDOTIC COMA, UNCONSCIOUSNESS, HYPERGLYCEMIA AND SEVERE METABOLIC DISRUPTION. DURING THE PT'S HOSPITALIZATION BLOOD GLUCOSE LEVELS (MMOL/L) WERE AS FOLLOWS: 97, 103 (11/2000), 84, 51, 25.6, 15.4 AND 9.2 (DATES OF RESULTS 1 AND 3-7 NOT PROVIDED). THE PT REC'D APPROPRIATE CORRECTIVE TREATMENT FOR THE DIABETIC KETOACIDOTIC COMA INCLUDING: HUMULIN R, HUMULIN N, SALINE AND RINGER INFUSION, NAHCO3, KCL, CLEXANE AND AMPICILIN. IN 12/2000, THE PT WAS TRANSFERRED TO THE INTERNAL DEPT OF THE HOSP. THE FAMILY MEMBER BROUGHT BOTH PENS TO THE REPORTER, WHO SUSPECTED ONE PEN FOR MALFUNCTION - THE PISTON DID NOT MOVE AND IT WAS APPARENT, THAT THE PT DID NOT RECEIVE ANY INSULIN. HOWEVER, THE RPTR COULD NOT EXCLUDE THAT THE PT DID NOT ASSEMBLE THE PEN CORRECTLY. A LILLY REP CONTACTED THE STAFF OF THE HOSP WHERE THE PT WAS HOSPITALIZED. FOLLOW UP INFO REVEALED THAT DURING THE COURSE OF THE HOSPITALIZATION, THE CONDITION OF THE PT GRADUALLY IMPROVED. INITIALLY, GOOD CONTROL OF THE PT'S DIABETES WAS ATTAINED, HOWEVER FOLLOWING EXACERBATION OF THE PT'S CHRONIC BRONCHITIS SLIGHT DESTABILIZATION OF THE DIABETES OCCURRED. FOLLOWING THIS IT WAS MORE DIFFICULT TO MANAGE THE PT'S BLOOD GLUCOSE LEVELS. AFTER AN IMPROVEMENT IN THE BRONCHITIS THE PT WAS DISCHARGED FROM HOSP AT PT'S OWN REQUEST, WITH ONLY BORDERLINE CONTROL OF DIABETES. THE ATTENDING STAFF OF THE HOSP STATED THAT THE PT'S FAMILY MEMBER BROUGHT THE PENS TO THE HOSP AND IT WAS FOUND THAT THE CARTRIDGE WAS INCORRECTLY INSERTED AND THE CAP OF THE CARTRIDGE WAS NOT INCORRECTLY INSERTED AND THE CAP OF THE CARTRIDGE WAS NOT REMOVED. THE PT IS CURRENTLY TREATED WITH THE SAME PENS, WHICH ARE WORKING CORRECTLY. THE PENS HAVE BEEN RETURNED FOR ANALYSIS. THE DIABETOLOGIST MENTIONED THAT VERY RECENTLY THE PT'S SPOUSE DIED AND SINCE THEN PT HAS BEEN IN A VERY POOR PSYCHOLOGICAL CONDITION. THE DIABETOLOGIST THINKS THAT THE PT'S DEPRESSION COULD HAVE CONTRIBUTED TO EVENTUAL IMPROPER USAGE OF THE PEN. THE EVENT WAS CONSIDERED UNRELATED TO HUMULIN N AND R BUT RELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13946 HUMAPEN ERGO 3 ML PEN INJECTOR KZE ELI LILLY AND CO MS8335 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R BRAND: HUMAPEN ERGO 3 ML TYPE: PEN INJECTOR| THERAPY DATES TO: 11/2000 00:00:00 FROM: NI| DURATION: NI.