BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMAPEN ERGO BURGUNDY/CLEAR

    MDR report key: 3061310 · Received April 16, 2013

    Report

    Report Number
    1819470-2013-00016
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 19, 2013
    Manufacturer
    ELI LILLY AND COMPANY
    Product Code
    NSC
    PMA / PMN Number
    K982842
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    NO FURTHER FOLLOW UP IS PLANNED. EVALUATION SUMMARY THE MOTHER OF A PATIENT REPORTED THAT HER DAUGHTER WAS NOT GETTING INSULIN OUT OF HER HUMAPEN ERGO DEVICE. HER DAUGHTER EXPERIENCED HIGH BLOOD GLUCOSE LEVELS. INVESTIGATION OF THE RETURNED DEVICE (BATCH 0603A04, MANUFACTURED MARCH 2006) FOUND THAT THE DEVICE MET DOSE ACCURACY AND GLIDE (INJECTION) FORCE SPECIFICATIONS. NO MALFUNCTION WAS IDENTIFIED. BASED ON THE INFORMATION PROVIDED, THE DEVICE WAS USED FOR 5 YEARS. THE USER MANUAL STATES THE HUMAPEN ERGO IS DESIGNED TO BE USED FOR UP TO 3 YEARS AFTER FIRST USE. THERE IS EVIDENCE OF IMPROPER USE. THE PATIENT USED THE DEVICE BEYOND THE RECOMMENDED USE PERIOD.

    Description of Event or Problem · 1

    (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 INCLUDED AN ADMISSION AT INTENSIVE CARE UNIT DUE TO KETOACIDOSIS WHEN THE PATIENT WAS (B)(6) (DATE NOT PROVIDED). AT THIS TIME, THE PATIENT WAS DIAGNOSED WITH DIABETES. THE CONCOMITANT MEDICATION INCLUDED LOSARTAN FOR TREATMENT OF KIDNEY DISORDER AND INSULIN GLARGINE FOR UNKNOWN TREATMENT. THE PATIENT RECEIVED INSULIN LISPRO (HUMALOG LISPRO) 1 TO 2 IU, FOUR OR FIVE TIMES (REPORTED AS DEPENDING OF CARBOHYDRATE COUNTING), SUBCUTANEOUSLY IN BELLY AND ARM, BEGINNING APPROXIMATELY IN 2008, FOR DIABETES MELLITUS. ON UNSPECIFIED DATE, UNKNOWN TIME AFTER INSULIN LISPRO INITIATION, THE PATIENT EXPERIENCED KIDNEY LESION DUE TO DIABETES. THIS EVENT WAS CONSIDERED SERIOUS DUE TO MEDICAL SIGNIFICANCE. IT WAS UNKNOWN IF SHE HAD RECEIVED CORRECTIVE TREATMENT, OR UNDERWENT LABORATORY EXAMS FOR THIS EVENT, BUT SHE CONTINUED TO HAVE A RENAL LESION. ON (B)(6) 2013, APPROXIMATELY FIVE YEARS AFTER BEGINNING INSULIN LISPRO TREATMENT VIA HUMAPEN ERGO BURGUNDY PEN BODY (LOT NUMBER 0603A04) WITH A CLEAR CARTRIDGE HOLDER ATTACHED, THE PATIENT WAS FEELING BAD WITH BLOOD GLUCOSE THAT REACHED 510 OR 520 (UNITS NOT PROVIDED); DUE TO THAT, SHE WAS TAKEN TO THE HOSPITAL AND WAS DISCHARGED WHEN HER BLOOD GLUCOSE DECREASED TO 250 (UNITS NOT PROVIDED). THIS SITUATION OCCURRED MANY TIMES DURING EIGHT DAYS. ON (B)(6) 2013, AT THE HOSPITAL, THE REPORTER CHECKED THE DEVICE AND NOTICED THAT IT WAS NOT DELIVERING INSULIN CORRECTLY. SINCE THEN, THE PATIENT WAS RECEIVING INSULIN WITH SYRINGE, AFTER THAT, HER BLOOD GLUCOSE REACHED 300 (UNITS NOT PROVIDED) AND WAS DECREASING (AS REPORTED). SHE ALSO RECEIVED SERUM, AT HOSPITAL. AS CORRECTIVE TREATMENT, THE INSULIN LISPRO DOSAGE WAS INCREASED IN 1 IU (UNCLEAR) AND INSULIN GLARGINE DOSAGE WAS FROM 18 IU TO 22 IU (UNKNOWN FREQUENCY). IT WAS NOT REPORTED IF SHE HAD RECOVERED FROM EVENT OF FEELING BAD. THIS CASE WAS ASSOCIATED TO (B)(4). THE REPORTER OPERATED THE DEVICE AND SHE WAS A TRAINED USER. THE PATIENT HAD USED THE REPORTED DEVICE FOR FIVE YEARS AND IT WAS UNKNOWN HOW LONG SHE HAD USED THIS DEVICE MODEL. THE DEVICE RETURNED ON (B)(4) 2013. UPON EVALUATION, NO MALFUNCTION WAS FOUND. THE DEVICE MET DOSE ACCURACY AND GLIDE FORCE SPECIFICATIONS. THE CONSUMER REPORTER DID NOT PROVIDE AN OPINION OF RELATEDNESS. UPDATE(B)(4) 2013: ADDITIONAL INFORMATION RECEIVED FROM CALL CENTER ON (B)(4) 2013 REGARDING THE INITIAL REPORT OF (B)(4) 2013 WAS PROCESSED WITH INITIAL CASE ENTRY. UPDATE (B)(4) 2013: PER INTERNAL REVIEW. CORRECTED DATE IN THIRD PARAGRAPH FROM (B)(4) 2012. UPDATE (B)(4) 2013: PER INTERNAL REVIEW ON (B)(4) 2013. CORRECTED DEVICE MODEL FROM HUMAPEN ERGO II TO HUMAPEN ERGO BURGUNDY PEN BODY WITH A CLEAR CARTRIDGE HOLDER ATTACHED, SINCE PRODUCT COMPLAINT AREA CONFIRMED ON (B)(4) 2013 WHAT MODEL THE REPORTED LOT NUMBER CORRESPONDED TO. UPDATED CORRESPONDING FIELDS AND NARRATIVE ACCORDINGLY. UPDATE (B)(4) 2013: UPON REVIEW OF THIS CASE ON (B)(4) 2013, THE CASE WAS OPENED TO UPDATE THE MEDWATCH FIELDS. UPDATE (B)(4) 2013: ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013, REGARDING INITIAL REPORTER DID NOT INCLUDE ANY RELEVANT INFORMATION. UPDATE (B)(4) 2013: ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013 FROM THE GLOBAL PRODUCT COMPLAINT DATABASE ADDED THE DEVICE SPECIFIC SAFETY SUMMARY; ADDED THE RERUN DATE OF THE DEVICE; UPDATED THE MALFUNCTION FIELD TO NO; UPDATED THE IMPROPER USE AND STORAGE TO YES; UPDATED THE MEDWATCH AND EU/CA REPORTING FIELDS; AND UPDATED THE NARRATIVE.

    Description of Event or Problem · 1

    LILLY CASE ID: (B)(6). 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 INCLUDED AN ADMISSION AT INTENSIVE CARE UNIT DUE TO KETOACIDOSIS WHEN THE PATIENT WAS ONE YEAR OLD (DATE NOT PROVIDED). AT THIS TIME, THE PATIENT WAS DIAGNOSED WITH DIABETES. THE CONCOMITANT MEDICATION INCLUDED LOSARTAN FOR TREATMENT OF KIDNEY DISORDER AND INSULIN GLARGINE FOR UNKNOWN TREATMENT. THE PATIENT RECEIVED INSULIN LISPRO (HUMALOG LISPRO) 1 TO 2 IU, FOUR OR FIVE TIMES (REPORTED AS DEPENDING OF CARBOHYDRATE COUNTING), SUBCUTANEOUSLY IN BELLY AND ARM, BEGINNING APPROXIMATELY IN 2008, FOR DIABETES MELLITUS. ON UNSPECIFIED DATE, UNKNOWN TIME AFTER INSULIN LISPRO INITIATION, THE PATIENT EXPERIENCED KIDNEY LESION DUE TO DIABETES. THIS EVENT WAS CONSIDERED SERIOUS DUE TO MEDICAL SIGNIFICANCE. IT WAS UNKNOWN IF SHE HAD RECEIVED CORRECTIVE TREATMENT, OR UNDERWENT LABORATORY EXAMS FOR THIS EVENT, BUT SHE CONTINUED TO HAVE A RENAL LESION. ON (B)(6) 2013, APPROXIMATELY FIVE YEARS AFTER BEGINNING INSULIN LISPRO TREATMENT VIA HUMAPEN ERGO BURGUNDY PEN BODY (LOT NUMBER 0603A04) WITH A CLEAR CARTRIDGE HOLDER ATTACHED, THE PATIENT WAS FEELING BAD WITH BLOOD GLUCOSE THAT REACHED 510 OR 520 (UNITS NOT PROVIDED); DUE TO THAT, SHE WAS TAKEN TO THE HOSPITAL AND WAS DISCHARGED WHEN HER BLOOD GLUCOSE DECREASED TO 250 (UNITS NOT PROVIDED). THIS SITUATION OCCURRED MANY TIMES DURING EIGHT DAYS. ON (B)(4) 2013, AT THE HOSPITAL, THE REPORTER CHECKED THE DEVICE AND NOTICED THAT IT WAS NOT DELIVERING INSULIN CORRECTLY. SINCE THEN, THE PATIENT WAS RECEIVING INSULIN WITH SYRINGE, AFTER THAT, HER BLOOD GLUCOSE REACHED 300 (UNITS NOT PROVIDED) AND WAS DECREASING (AS REPORTED). SHE ALSO RECEIVED SERUM, AT HOSPITAL. AS CORRECTIVE TREATMENT, THE INSULIN LISPRO DOSAGE WAS INCREASED IN 1 IU (UNCLEAR) AND INSULIN GLARGINE DOSAGE WAS FROM 18 IU TO 22 IU (UNKNOWN FREQUENCY). IT WAS NOT REPORTED IF SHE HAD RECOVERED FROM EVENT OF FEELING BAD. THIS CASE WAS ASSOCIATED TO PC (B)(4). THE REPORTER OPERATED THE DEVICE AND SHE WAS A TRAINED USER. THE PATIENT HAD USED THE REPORTED DEVICE FOR FIVE YEARS AND IT WAS UNKNOWN HOW LONG SHE HAD USED THIS DEVICE MODEL. THE DEVICE RETURN WAS EXPECTED. THE CONSUMER REPORTER DID NOT PROVIDE AN OPINION OF RELATEDNESS. UPDATE (B)(6) 2013: ADDITIONAL INFORMATION RECEIVED FROM CALL CENTER ON (B)(6) 2013, REGARDING THE INITIAL REPORT OF (B)(6) 2013, WAS PROCESSED WITH INITIAL CASE ENTRY. UPDATE (B)(6) 2013: PER INTERNAL REVIEW. CORRECTED DATE IN THIRD PARAGRAPH FROM (B)(6) 2012 TO (B)(6) 2013. UPDATE (B)(6) 2013: PER INTERNAL REVIEW ON (B)(6) 2013. CORRECTED DEVICE MODEL FROM HUMAPEN ERGO II TO HUMAPEN ERGO BURGUNDY PEN BODY WITH A CLEAR CARTRIDGE HOLDER ATTACHED, SINCE PRODUCT COMPLAINT AREA CONFIRMED ON (B)(6) 2013 WHAT MODEL THE REPORTED LOT NUMBER CORRESPONDED TO. UPDATED CORRESPONDING FIELDS AND NARRATIVE ACCORDINGLY. UPDATE: (B)(6) 2013: UPON REVIEW OF THIS CASE ON (B)(6) 2013, THE CASE WAS OPENED TO UPDATE THE MEDWATCH FIELDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163671 HUMAPEN ERGO BURGUNDY/CLEAR FOR TREATMENT PURPOSES NSC ELI LILLY AND COMPANY MS8930 0603A04

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Hospitalization LOSARTAN| HUMALOG| LANTUS