BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMAPEN ERGO, TEAL/CLEAR

    MDR report key: 1001039 · Received February 20, 2008

    Report

    Report Number
    1819470-2008-00010
    Event Type
    Injury
    Date Received
    February 20, 2008
    Date of Event
    January 20, 2008
    Report Date
    January 21, 2008
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    FMF
    PMA / PMN Number
    K982842
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF DEVICE IS RETURNED, EVALUATION WILL BE PERFORMED TO DETERMINE IF A MALFUNCTION HAS OCCURRED. NOTE: THIS IS AN INITIAL REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE FINAL EVALUATION IS COMPLETED. THIS REPORT IS ASSOCIATED WITH 1819470-2008-00008 AND 1819470-2008-00009, SINCE THERE IS MORE THAN ONE DEVICE IMPLICATED.

    Description of Event or Problem · 1

    THIS DEVICE CASE, REPORTED BY A CONSUMER AND SUBMITTED BY A PHARMACIST WHO RETURNED THE DEVICE TO THE COMPANY, CONCERNS A FEMALE PATIENT. THE PATIENT'S MEDICAL HISTORY INCLUDED CARDIAC DISORDER, STENT SURGERY, DIABETES MELLITUS FOR THE PAST 27 YEARS, DIABETIC NEUROPATHY, AND RETINOPATHY. CONCOMITANT MEDICATIONS INCLUDED INSULIN GLARGINE, ACETYLSALICYLIC ACID, CLOPIDOGREL SULFATE, LEVOTHYROXINE, NEBIVOLOL HYDROCHLORIDE, UNSPECIFIED ANTIHYPERTENSIVE AGENTS, AND OTHER UNSPECIFIED ANTIHYPERTENSIVE AGENTS, AND OTHER UNSPECIFIED ANTIDIABETIC AGENTS, ALL FOR THE TREATMENT OF UNKNOWN CONDITIONS. THE PATIENT WAS TAKING INSULIN LISPRO (HUMALOG), APPROXIMATELY 10 UNITS EACH MORNING, 14 UNITS AT LUNCHTIME AND 15 UNITS EACH EVENING, SUBCUTANEOUSLY, FOR THE TREATMENT OF DIABETES MELLITUS, BEGINNING ON AN UNSPECIFIED DATE IN 2004. IN 2008, TIME OF EVENT ONSET UNKNOWN AFTER BEGINNING INSULIN LISPRO VIA A HUMAPEN ERGO TEAL/CLEAR (LOT NUMBER 0604A02), THE PATIENT EXPERIENCED INCREASED BLOOD GLUCOSE WITH A READING OF 20.3 MMOL/L (NORMAL RANGE NOT PROVIDED), REPORTED BY THE CONSUMER TO BE DUE TO THE DEFECTIVE PEN. THE EVENT WAS CONSIDERED TO BE SERIOUS FOR OTHER REASONS DUE TO MEDICAL SIGNIFICANCE BY THE COMPANY PHYSICIAN. IT WAS REPORTED THAT THE PATIENT HAD IN TOTAL THREE PENS (LOT NUMBERS 0604A02, UNKNOWN FOR OTHER TWO PENS), TWO OF THEM WHICH WERE NEW. THE INJECTIONS SCREW WAS REPORTED TO BE DEFECTIVE (JAMMED) IN ALL THREE OF THE PENS IN SPITE OF THEM BEING NEW. THE PATIENT REPORTED THAT SHE WAS UNABLE TO INJECT WITH THESE PENS AND INSULIN COULD NOT BE RELEASED FROM THE PENS. THE PATIENT WENT ON THE SAME DAY TO THE HOSPITAL THAT NIGHT (20:00 PM) WHERE SHE RECEIVED OTHER PENS. THE PATIENT THEN INJECTED 40 UNITS ONCE AND WAS TOLD TO INJECT 2.5 TIMES LESS. THE PATIENT LEFT ONE OF THE DEFECTIVE PENS AT THE HOSP, THE OTHER ONE SHE LEFT AT A PHARMACY THAT WAS OPEN THAT DAY, AND THE SHE RETURNED THE THIRD PEN TO HER REGULAR PHARMACY WHO THEN REPORTEDLY RETURNED THAT PEN TO QUALITY CONTROL. NO OTHER RELEVANT PATIENT PHYSICAL FINDINGS WERE REPORTED. IT WAS NOT REPORTED WHETHER THE PATIENT RECEIVED ANY CORRECTIVE TREATMENT FOR THE EVENT, AND THE PATIENT FULLY RECOVERED FROM THE EVENT ON AN UNREPORTED DATE. IT WAS UNKNOWN WHETHER INSULIN LISPRO TREATMENT WAS BEING CONTINUED. THE HUMAPEN ERGO TEAL/CLEAR COMPLAINTS ARE ASSOCIATED WITH ANOTHER THREE DEVICES. THE PATIENT WAS THE OPERATOR OF THE DEVICE BUT IT WAS UNKNOWN WHETHER THE PATIENT WAS A TRAINED USER. THE PATIENT HAD USED THE DEVICE MODEL FOR AN UNKNOWN PERIOD OF TIME. IF THE DEVICE IS RETURNED, EVALUATION WILL BE PERFORMED TO DETERMINE IF A MALFUNCTION HAS OCCURRED. IT WAS REPORTED THAT THE PATIENT WAS CONTINUING TO USE THE HUMAPEN ERGO TEAL/CLEAR. THE REPORTING PHARMACIST DID NOT PROVIDE AN OPINION OF RELATEDNESS BETWEEN INSULIN LISPRO AND THE EVENT OR BETWEEN THE EVENT AND THE DEVICE; HOWEVER, THE CONSUMER STATED THAT THEY SAW A CAUSALITY BETWEEN THE DEVICE AND THE EVENT. UPDATE 17-FEB-2008: ADDITIONAL INFORMATION RECEIVED IN GPCMS ON 15-FEB-2008. ADDED LOT NUMBER FOR EXISTING CID AND ADDED TWO ADDITIONAL CID NUMBERS (CODED TWO ADDITIONAL DEVICES). UPDATED CORRESPONDING FIELDS AND NARRATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO, TEAL/CLEAR PEN INJECTOR FOR TREATMENT PURPOSES FMF ELI LILLY AND CO. MS8929 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other