BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMAPEN ERGO BURGUNDY/CLEAR

    MDR report key: 2962079 · Received February 14, 2013

    Report

    Report Number
    1819470-2013-00003
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 2013
    Manufacturer
    ELI LILLY AND COMPANY
    Product Code
    NSC
    PMA / PMN Number
    K982842
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: A PATIENT REPORTED THAT THE INJECTION BUTTON OF HER HUMAPEN ERGO DEVICE JAMMED, CAUSING HER TO PRESS WITH FORCE, AND CAUSING INJECTION SITE INJURY. SHE EXPERIENCED UNSTABLE BLOOD SUGARS. INVESTIGATION OF THE RETURNED DEVICE (BATCH 0403A40, MANUFACTURED MARCH 2004) FOUND THAT THE DEVICE MET DOSE ACCURACY AND GLIDE (INJECTION) FORCE SPECIFICATIONS. NO MALFUNCTION WAS IDENTIFIED. THERE IS EVIDENCE OF IMPROPER USE. THE USER DOES NOT ALWAYS PRIME THE DEVICE WHICH MAY BE RELEVANT TO THE COMPLAINT.

    Additional Manufacturer Narrative · 1

    IF DEVICE IS RETURNED, EVALUATION WILL BE PERFORMED TO DETERMINE IF A MALFUNCTION HAS OCCURRED. THIS IS AN INITIAL REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE FINAL EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    (B)(4). IF DEVICE IS RETURNED, EVALUATION WILL BE PERFORMED TO DETERMINE IF A MALFUNCTION HAS OCCURRED. THIS IS AN INITIAL REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE FINAL EVALUATION IS COMPLETED. THIS SPONTANEOUS CASE, REPORTED BY A CONSUMER WHO CONTACTED THE COMPANY TO REPORT A PRODUCT COMPLAINT AND ADVERSE EVENTS, CONCERNS A (B)(6) FEMALE PATIENT. THE MEDICAL HISTORY WAS NOT PROVIDED. THE CONCOMITANT MEDICATIONS INCLUDED FLUOXETINE FOR ANXIETY, PIOGLITAZONE HYDROCHLORIDE AND METFORMIN FOR DIABETES, SIMVASTATIN FOR CHOLESTEROL, ENALAPRIL MALEATE + HYDROCHLOROTHIAZIDE FOR BLOOD PRESSURE HIGH AND INSULIN GLARGINE FOR UNSPECIFIED INDICATION. THE PATIENT RECEIVED INSULIN LISPRO (HUMALOG LISPRO) 24 IU, THREE TIMES A DAY, SUBCUTANEOUSLY, FOR UNKNOWN TREATMENT AND START DATE. SINCE APPROXIMATELY 2005, UNKNOWN TIME AFTER INSULIN LISPRO INITIATION, THE PATIENT WAS RECEIVING MEDICATION VIA HUMAPEN ERGO BURGUNDY WITH CLEAR CARTRIDGE HOLDER (LOT NUMBER 0403A40). APPROXIMATELY ON (B)(6) 2012, THE PATIENT STARTED TO NOTICE THAT THE INJECTION BUTTON OF DEVICE WAS JAMMING DURING ROTATION; SOMETIMES THE FUNCTION FAILED AND THE PATIENT HAD TO PRESS THE BUTTON WITH STRENGTH. DUE TO THIS, SHE EXPERIENCED TOO MUCH BLEEDING, PURPLE MARKS, LUMPS AND BURNING AT INJECTION SITE (BELLY). THE PATIENT USED TO INJECT IN THE ARMS AND LEGS, BUT, ON UNSPECIFIED DATE, SHE CHANGED THE INJECTIONS TO BELLY AS SHE COULD NOT STAND THE INJECTIONS ANYMORE (INFORMATION UNCLEAR). IT WAS ALSO REPORTED THAT HER BLOOD GLUCOSE WAS DECOMPENSATED. ON (B)(6) 2013, THE PATIENT MEASURED HER BLOOD GLUCOSE AT MORNING (FASTING) AND IT WAS 460 (UNITS NOT PROVIDED) AND RIGHT AFTER THAT, IT WAS MEASURED AGAIN AND THE VALUE WAS 30 (UNITS NOT PROVIDED). THE BLOOD GLUCOSE INCREASED AND BLOOD GLUCOSE DECREASED WERE CONSIDERED SERIOUS EVENTS BY THE COMPANY DUE TO MEDICALLY SIGNIFICANT REASONS. THE PATIENT RELATED THE BLOOD GLUCOSE ABNORMAL TO THE DEATH OF HER HUSBAND, ON (B)(6) 2012. SHE DID NOT RECEIVE CORRECTIVE TREATMENT FOR ALL EVENTS AND THEY DID NOT RESOLVE. THE INSULIN LISPRO TREATMENT WAS CONTINUED. THE PATIENT OPERATED THE DEVICE AND SHE WAS A TRAINED USER. THE PATIENT HAD USED THE REPORTED DEVICE FOR EIGHT DAYS AND IT WAS UNKNOWN HOW LONG HE HAD USED THIS DEVICE MODEL. THE DEVICE RETURN WAS EXPECTED. THE CONSUMER REPORTER DID NOT PROVIDE AN OPINION OF RELATEDNESS. EDIT (B)(4) 2013: UPON REVIEW THE CASE WAS UNLOCKED FOR A NOT MEDICALLY SIGNIFICANT EDIT ON EU/CA FIELD. NO OTHER CHANGES TO THE CASE. UPDATE (B)(4) 2013: UPON REVIEW OF THIS CASE ON (B)(4) 2013, THE CASE WAS OPENED TO COMPLETE THE MEDWATCH FIELDS.

    Description of Event or Problem · 1

    LILLY CASE ID: (B)(4). THIS SPONTANEOUS CASE, REPORTED BY A CONSUMER WHO CONTACTED THE COMPANY TO REPORT A PRODUCT COMPLAINT AND ADVERSE EVENTS, CONCERNS A (B)(6) CAUCASIAN FEMALE PATIENT. THE MEDICAL HISTORY WAS NOT PROVIDED. THE CONCOMITANT MEDICATIONS INCLUDED FLUOXETINE FOR ANXIETY, PIOGLITAZONE HYDROCHLORIDE AND METFORMIN FOR DIABETES, SIMVASTATIN FOR CHOLESTEROL, ENALAPRIL MALEATE + HYDROCHLOROTHIAZIDE FOR BLOOD PRESSURE HIGH AND INSULIN GLARGINE FOR UNSPECIFIED INDICATION. THE PATIENT RECEIVED INSULIN LISPRO (HUMALOG LISPRO) 24 IU, THREE TIMES A DAY, SUBCUTANEOUSLY, FOR UNKNOWN TREATMENT AND START DATE. SINCE APPROXIMATELY 2005, UNKNOWN TIME AFTER INSULIN LISPRO INITIATION, THE PATIENT WAS RECEIVING MEDICATION VIA HUMAPEN ERGO BURGUNDY WITH CLEAR CARTRIDGE HOLDER (LOT NUMBER 0403A40 / MANUFACTURED DATE MAR2004). APPROXIMATELY ON (B)(6) 2012, THE PATIENT STARTED TO NOTICE THAT THE INJECTION BUTTON OF DEVICE WAS JAMMING DURING ROTATION; SOMETIMES THE FUNCTION FAILED AND THE PATIENT HAD TO PRESS THE BUTTON WITH STRENGTH. DUE TO THIS, SHE EXPERIENCED TOO MUCH BLEEDING, PURPLE MARKS, LUMPS AND BURNING AT INJECTION SITE (BELLY). THE PATIENT USED TO INJECT IN THE ARMS AND LEGS, BUT, ON UNSPECIFIED DATE, SHE CHANGED THE INJECTIONS TO BELLY AS SHE COULD NOT STAND THE INJECTIONS ANYMORE (INFORMATION UNCLEAR). IT WAS ALSO REPORTED THAT HER BLOOD GLUCOSE WAS DECOMPENSATED. ON (B)(6) 2013, THE PATIENT MEASURED HER BLOOD GLUCOSE AT MORNING (FASTING) AND IT WAS 460 (UNITS NOT PROVIDED) AND RIGHT AFTER THAT, IT WAS MEASURED AGAIN AND THE VALUE WAS 30 (UNITS NOT PROVIDED). THE BLOOD GLUCOSE INCREASED AND BLOOD GLUCOSE DECREASED WERE CONSIDERED SERIOUS EVENTS BY THE COMPANY DUE TO MEDICALLY SIGNIFICANT REASONS. THE PATIENT RELATED THE BLOOD GLUCOSE ABNORMAL TO THE DEATH OF HER HUSBAND, ON SEP-2012. SHE DID NOT RECEIVE CORRECTIVE TREATMENT FOR ALL EVENTS AND THEY DID NOT RESOLVE. THE INSULIN LISPRO TREATMENT WAS CONTINUED. THE PATIENT OPERATED THE DEVICE AND SHE WAS A TRAINED USER (LOT NUMBER: 0403A40; ASSOCIATED WITH PRODUCT COMPLAINT: (B)(4)). THE PATIENT HAD USED THE REPORTED DEVICE FOR EIGHT YEARS AND IT WAS UNKNOWN HOW LONG HE HAD USED THIS DEVICE MODEL. THE DEVICE WAS RETURNED (B)(6) 2013, AND NO MALFUNCTION WAS FOUND. THE CONSUMER REPORTER DID NOT PROVIDE AN OPINION OF RELATEDNESS. EDIT (B)(4) 2013: UPON REVIEW THE CASE WAS UNLOCKED FOR A NOT MEDICALLY SIGNIFICANT EDIT ON EU/CA FIELD. NO OTHER CHANGES TO THE CASE. UPDATE 31-JAN-2013: UPON REVIEW OF THIS CASE ON (B)(4) 2013, THE CASE WAS OPENED TO COMPLETE THE MEDWATCH FIELDS. UPDATE 05MAR2013: ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013 FROM THE GLOBAL PRODUCT COMPLAINT DATABASE. ADDED THE DEVICE SPECIFIC SAFETY SUMMARY, MANUFACTURED DATE AND RETURN DATE OF THE DEVICE; UPDATED THE MALFUNCTION FIELD TO NO AND THE IMPROPER USE AND STORAGE TO YES; UPDATED THE MEDWATCH AND EU/CA FIELDS; AND UPDATED THE NARRATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64914 HUMAPEN ERGO BURGUNDY/CLEAR FOR TREATMENT PURPOSES NSC ELI LILLY AND COMPANY MS8930 0403A40

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other FLUOXETINE| LANTUS| RENITEC| METFORMIN| ACTOS| SIMVASTATIN| HUMALOG