BEUDAMED
    FDA Adverse Event Other Summary report: N

    HUMAPEN ERGO, TEAL/CLEAR

    MDR report key: 345237 · Received August 2, 2001

    Report

    Report Number
    1819470-2001-00037
    Event Type
    Other
    Date Received
    August 2, 2001
    Date of Event
    June 29, 2001
    Report Date
    July 4, 2001
    Manufacturer
    ELI LILLY AND COMPANY
    Product Code
    KZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE CASE, REPORTED BY A DIABETES SPECIALIST NURSE, CONCERNS A PT WHO EXPERIENCED DIABETIC KETOACIDOSIS (DKA). THE PT WAS USING A PEN INJECITON DEVICE (HUMAPEN ERGO/CLEAR CARTRIDGE HOLDER) TO DELIVER 20% SOLUBLE INSULIN/80% ISOPHANE INSULIN (HUMULIN M3). THE PT'S MEDICAL HISTORY INCLUDED HAVING DIABETES FOR SEVERAL YEARS. THE PT NEVER HAD PROBLEMS PRIOR TO THE USE OF THE PEN INJECTION DEVICE, WHEN PT USED INSULIN VIALS. THE PT WAS NOT TAKING CONCOMITANT MEDICATION. THE PT EXPERIENCED DKA IN 2001 AND WAS HOSPITALIZED WHILE USING A PEN INJECTION DEVICE TO DELIVERY 20% SOLUBLE INSULIN 80% ISOPHANE INSULIN. THE PT HAD RECENTLY TRANSFERRED TO USING THE PEN INJECTION DEVICE FROM USING 10ML VIALS. THE RPTR STATED THAT PT THOUGHT THE PT WAS NOT USING THE PEN PROPERLY AND WAS DIALING IT BACKWARDS. ACTION WITH 20% SOLUBLE INSULIN/80% ISOPHANE INSULIN IS UNKNOWN. THE PT IS RECOVERING. THE RPTR DID NOT KNOW IF THE EVENT WAS RELATED TO THE PEN INJECTION DEVICE. THE RPTR DOES NOT CONSIDER THE EVENT TO BE RELATED TO 20% SOLUBLE INSULIN/80% ISOPHANE INSULIN. FURTHER INFO HAS BEEN REQUESTED. THE PEN IS TO BE RETURNED. THIS CASE IS CROSS REFERENCED TO CID 106863. UPDATE 07/2001: PRELIMINARY REPORT PREPARED.

    Description of Event or Problem · 1

    THE PT'S MEDICAL HISTORY INCLUDED HAVING DIABETES FOR SEVERAL YEARS. THE SECOND RPTR STATED: IT WAS THE PEN THAT WAS NOT CONNECTED THE RIGHT WAY AND THAT IS WHY THE PT WAS NOT GETTING ANY INSULIN AT ALL AND PT MISSED DELIVERING 140UNITS OF INSULIN. THE SECOND RPTR STATED THE PT WAS REALLY UNWELL AND WAS ON A DRIP. THE SECOND RPTR REVEALED: WHEN THE PT WAS AT CASAULTY THE TREATING NURSE CONNECTED THEIR PEN CORRECTLY. INITIAL EXAMINATION OF THE RETURNED PEN INJECTION DEVICE REVEALED THE PEN HAD NO DEFECTS. THE EVENT ENDED IN 7/2001. THE PT HAS NOT BEEN TO WORK FOR SIX WEEKS. THE INITIAL RPTR DOES NOT CONSIDER THE EVENT TO BE RELATED TO THE PEN INJECTION DEVICE. THE INITIAL RPTR STATED THAT IT WAS FELT THAT HUMAN ERROR WAS THE CAUSE OF THE PT EVENT. DETAILED INVESTIGATION FOUND THE PEN WITHIN SPECS FOR DOSE ACCURACY AND INJECTION FORCE. QUALITY ASSURANCE REPORTED THAT IT CANNOT BE CONCLUDED THAT THE REPORTED EVENT WAS CAUSED BY A DEVICE MALFUNCTION. UPDATE 30-AUG-2001: FURTHER INFO RECEIVED FROM NON-HEALTHCARE PROFESSIONAL. EVENT INFO AND COMPLAINT DETAILS. ADDITIONAL CONTACT. NOTIFIED BY QUALITY ASSURANCE THAT PEN HAD BEEN RETURNED. DEVICE INFO. NO DEFECTS. FINAL ANALYSIS TO BE PERFORMED BY THE MFR. UPDATE 04-SEP-2001: FURTHER INFO RECEIVED FROM INITIAL RPTR ON 30-AUG-2001. ADDED STOP DATE O EVENTS, CONTACT INFO AND CAUSALITY ASSESSMENT. UPDATE 28-SEPT-2001: PRODUCT DELIVERY SYSTEMS (PDS) RESULTS AND CONCLUSIONS RECEIVED 28-SEPT-2001. DETAILED INVESTIGATION FOUND THE PEN WITHIN SPECS FOR DOSE ACCURACY AND INJECTION FORCE. QUALITY ASSURANCE REPORTED THAT IT CANNOT BE CONCLUDED THAT THE REPORTED EVENT WAS CAUSED BY A DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35088 HUMAPEN ERGO, TEAL/CLEAR PEN INJECTOR KZE ELI LILLY AND COMPANY MS8929 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization