BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMAPEN LUXURA HALF-DOSE PEN

    MDR report key: 2320966 · Received November 3, 2011

    Report

    Report Number
    1819470-2011-00128
    Event Type
    Injury
    Date Received
    November 3, 2011
    Date of Event
    September 30, 2011
    Report Date
    October 12, 2011
    Manufacturer
    ELI LILLY AND COMPANY
    Product Code
    NSC
    PMA / PMN Number
    K063151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT INCLUDES FINAL EVALUATION FINDINGS. NO ADDITIONAL INFORMATION IS EXPECTED. EVALUATION SUMMARY A PATIENT REPORTED THAT HER HUMAPEN LUXURA HD DEVICE DOES NOT COMPLETELY RESET AFTER INJECTION, BUT RATHER, THE PEN STAYS BETWEEN 0 AND 0.5. SHE EXPERIENCED HYPERGLYCEMIA WHICH LED TO A COMA. INVESTIGATION OF THE RETURNED DEVICE (BATCH 0911G01, MANUFACTURED NOVEMBER 2009) FOUND THAT THE DEVICE FUNCTIONED NORMALLY AND RETURNED TO ZERO AFTER INJECTION. THE DEVICE 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 TO REPORT A PRODUCT COMPLAINT, CONCERNS A (B)(6) FEMALE OF UNKNOWN ORIGIN. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE UNKNOWN. THE PATIENT RECEIVED INSULIN LISPRO (HUMALOG) CARTRIDGE VIA REUSABLE HUMAPEN LUXURA HALF DOSE, UNKNOWN DOSING REGIMEN, FOR THE TREATMENT OF AN UNKNOWN INDICATION BEGINNING ON AN UNKNOWN DATE. ON AN UNKNOWN DATE IT WAS REPORTED THE HUMAPEN DID NOT RETURN CONSISTENTLY TO ITS ZERO POSITION, IT REMAINED BETWEEN ZERO AND 0.5 FOLLOWING THE INJECTION (PRODUCT COMPLAINT FOR CARTRIDGE 1901899/LOT NUMBER UNKNOWN, PRODUCT COMPLAINT FOR DEVICE 1901902/LOT NUMBER 0911G01). THE PATIENTS GLYCEMIA REGULARLY CHANGED (DATE UNKNOWN). BLOOD SUGAR VALUES WERE UNKNOWN. IN (B)(6) 2011, SHE EXPERIENCED HYPERGLYCEMIA WHICH LED TO A COMA FOR WHICH SHE WAS TRANSFERRED TO THE EMERGENCY CARE UNIT (CONSIDERED AS MEDICALLY SIGNIFICANT). TREATMENT MEASURES AND DIAGNOSTIC TESTING WAS NOT PROVIDED. THE PATIENT REPORTEDLY FELT THAT CONSIDERING THE HUMAPEN LUXURA PROBLEM, INSULIN LISPRO INJECTIONS WERE INCOMPLETELY PERFORMED (DATE UNKNOWN). NO ADDITIONAL INFORMATION WAS PROVIDED. THE OUTCOME WAS RECOVERED FOR HYPERGLYCEMIA COMA AND THE OUTCOME WAS UNKNOWN FOR GLYCEMIA CHANGED AND INCOMPLETE INJECTIONS. IT WAS UNKNOWN IF THE INSULIN LISPRO WAS CONTINUED. THE PATIENT WAS A TRAINED OPERATOR OF THE PEN. THE DURATION OF USE OF THE SUSPECT PEN WAS APPROXIMATELY SEVEN MONTHS (SINCE (B)(6) 2011). THE PEN WAS RETURNED (B)(6) 2011. UPDATE 20-OCT-2011: ADDITIONAL INFORMATION RECEIVED ON 13-OCT-2011 FROM THE GLOBAL PRODUCT COMPLAINT SYSTEM: PRODUCT COMPLAINT FOR DEVICE ADDED. NO OTHER INFORMATION WAS PROVIDED. NARRATIVE UPDATED ACCORDINGLY. UPDATE 21OCT11: ADDITIONAL INFORMATION WAS RECEIVED ON 13OCT11 FROM THE PRODUCT COMPLAINT SAFETY DATABASE. LOT NUMBER A771544 WAS CORRECTED TO 0911G01. UPDATED THE PRODUCT TAB FOR HUMAPEN LUXURA HALF DOSE AND UPDATED THE NARRATIVE WITH THE CHANGE. THE MEDWATCH AND EU/CA FIELDS WERE ALSO UPDATED. UPDATE 02NOV2011: ADDITIONAL INFORMATION RECEIVED ON 01NOV2011 FROM THE GLOBAL PRODUCT COMPLAINT DATABASE ADDED THE DEVICE SPECIFIC SAFETY SUMMARY, THE RETURNED DATED AND MANUFACTURED DATE OF THE HUMAPEN LUXURA HALF DOSE; UPDATE THE MALFUNCTION FIELD TO NO; AND UPDATED THE MEDWATCH AND EU/CA FIELDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN LUXURA HALF-DOSE PEN FOR TREATMENT PURPOSES NSC ELI LILLY AND COMPANY MS9673 0911G01

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other HUMALOG