BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMAPEN LUXURA BURGUNDY

    MDR report key: 5067791 · Received September 10, 2015

    Report

    Report Number
    1819470-2015-00094
    Event Type
    Injury
    Date Received
    September 10, 2015
    Report Date
    July 6, 2015
    Manufacturer
    ELI LILLY AND COMPANY
    Product Code
    FMF
    PMA / PMN Number
    K142518
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO FURTHER FOLLOW UP IS PLANNED. EVALUATION SUMMARY: A CONSUMER REPORTED ON BEHALF OF A FEMALE PATIENT THAT HER HUMAPEN LUXURA INJECTION BUTTON WAS JAMMED OR HARD TO PRESS, AND THE CORRECT DOES OF INSULIN WAS NOT BEING ADMINISTERED. THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE LEVELS. THE INVESTIGATION OF THE RETURNED DEVICE ((B)(4), MANUFACTURED AUGUST 2008) FOUND THAT THE DEVICE MET FUNCTIONAL REQUIREMENTS AND MET DOSE ACCURACY AND GLIDE (INJECTION) FORCE SPECIFICATIONS. NO MALFUNCTION WAS IDENTIFIED. THERE IS NO EVIDENCE OF IMPROPER USE OR STORAGE.

    Description of Event or Problem · 1

    (B)(4). THIS SPONTANEOUS CASE, REPORTED BY A CONSUMER WHO CONTACTED THE COMPANY DUE TO A PRODUCT COMPLAINT, CONCERNS (B)(6) FEMALE PATIENT OF UNKNOWN ORIGIN. THE MEDICAL HISTORY WAS NOT PROVIDED. THE CONCOMITANT MEDICATION INCLUDED LEVOTHYROXINE SODIUM FOR THYROID DISORDER, METFORMIN FOR DIABETES, VALPROATE SODIUM, OLANZAPINE, VALPROATE SODIUM+ VALPROIC ACID, FLURAZEPAM HYDROCHLORIDE AND LEVOMEPROMAZINE, FOR UNKNOWN INDICATION FOR USE. THE PATIENT RECEIVED INSULIN 25% LISPRO + 75% NPL (HUMALOG MIX 25) CARTRIDGE, 10IU IN THE MORNING, AT LUNCH AND IN THE EVENING, SUBCUTANEOUSLY IN ABDOMEN ONLY, FOR TREATMENT OF DIABETES BEGINNING ON UNKNOWN DATE. IN (B)(6) 2015, UNKNOWN PERIOD OF TIME AFTER STARTING INSULIN 25% LISPRO + 75% NPL VIA HUMAPEN LUXURA BURGUNDY (LOT 0808B03), THE PATIENT WAS HOSPITALIZED DUE TO DIABETES. FURTHER INFORMATION REGARDING THE HOSPITALIZATION WAS NOT PROVIDED BUT THE PATIENT WAS DISCHARGED ON THE SAME MONTH. LABORATORIAL EXAMINATIONS, OUTCOME OF EVENT AND CORRECTIVE TREATMENT RECEIVED, IF ANY, WAS NOT PROVIDED. SINCE (B)(6) 2015, DUE TO UNKNOWN REASON, THE PATIENT WAS BEDRIDDEN AND USING DIPPER. ON UNKNOWN DATE, THE PATIENT EXPERIENCED WEAKNESS OF LIMBS, BLISTERS ON FOOT AND DRY MOUTH. THE BLISTERS ON FOOT WERE CONSIDERED SERIOUS BY THE COMPANY DUE TO ITS MEDICAL SIGNIFICANCE. IN THE WEEK OF (B)(6) 2015, UNKNOWN PERIOD OF TIME AFTER STARTING INSULIN 25% LISPRO + 75% NPL VIA HUMAPEN LUXURA BURGUNDY(LOT 0808B03), IT WAS NOTICED THE INJECTOR BUTTON WAS JAMMED AND DUE TO THAT, THE CORRECT DOSE OF INSULIN WAS NOT BEING ADMINISTERED AND THE PATIENT EXPERIENCED BLOOD GLUCOSE HIGH AND NOT CONTROLLED, REACHING APPROXIMATELY A VALUE OF 364(UNITS AND RANGE NOT PROVIDED). IN ADDITION, SINCE THE DEVICE PRESENTED THIS PROBLEM ((B)(4)), THE PATIENT WAS BEING HURT (AS REPORTED). AS CORRECTIVE MEASURE FOR BLOOD GLUCOSE HIGH, THE PATIENT RECEIVED THE USUAL DOSE OF INSULIN 25% LISPRO + 75% NPL BUT WAS NOT RECOVERED FROM EVENT. THE OUTCOME AND CORRECTIVE TREATMENT FOR WEAKNESS OF LIMBS, HURT, BLISTERS ON FOOT AND DRY MOUTH WAS NOT PROVIDED. THE PRIMING WAS ALWAYS PERFORMED AND THE NEEDLES WERE NEVER REUSED. THE INSULIN 25% LISPRO + 75% NPL THERAPY WAS CONTINUED. THE FRIEND AND BROTHER OF PATIENT WERE THE OPERATORS OF DEVICE AND THEY WERE TRAINED. THE COMPLAINED DEVICE HAD BEEN USED FOR APPROXIMATELY THREE YEARS BUT IT WAS UNKNOWN HOW LONG THIS DEVICE MODEL HAD BEEN USED. THE DEVICE WOULD RETURN. THE DEVICE WAS RETURNED ON 16JUL2015, AND NO MALFUNCTION WAS FOUND. THE REPORTER RELATED THE BLOOD GLUCOSE HIGH AND WRONG DOSE ADMINISTERED TO INSULIN 25% LISPRO + 75% NPL AND HUMAPEN LUXURA BURGUNDY AND STATED THE INJURY WAS CAUSED BY THE PROBLEM WITH HUMAPEN LUXURA BURGUNDY. AN OPINION OF RELATEDNESS FOR THE REMAINING EVENTS WAS NOT PROVIDED. UPDATE 07JUL2015: ADDITIONAL INFORMATION PROVIDED ON 06JUL2017 BY THE SAME REPORTER WAS PROCESSED WITHIN INITIAL CASE ENTRY. EDIT 16JUL2015: UPON REVIEW, ADDED PRODUCT COMPLAINT NUMBER IN CASE NARRATIVE. UPDATE 20AUG2015: ADDITIONAL INFORMATION RECEIVED ON 20AUG2015 FROM THE GLOBAL PRODUCT COMPLAINT DATABASE ADDED THE DEVICE SPECIFIC SAFETY SUMMARY, RETURN DATE OF THE DEVICE, AND MANUFACTURED DATE OF THE DEVICE; UPDATED THE MALFUNCTION FIELD TO NO; UPDATED THE MEDWATCH AND EU/CA FIELDS; AND UPDATED THE NARRATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600666 HUMAPEN LUXURA BURGUNDY FOR TREATMENT PURPOSES FMF ELI LILLY AND COMPANY MS9662 0808B03

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization METFORMIN