BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN MEMOIR

    MDR report key: 2052401 · Received April 13, 2011

    Report

    Report Number
    1819470-2011-00047
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Report Date
    March 18, 2011
    Manufacturer
    ELI LILLY AND COMPANY
    Product Code
    NSC
    PMA / PMN Number
    K053563
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT SUGGESTIVE OF REPORTABLE MALFUNCTION/INCIDENT. WILL INVESTIGATE FURTHER. THIS IS AN INITIAL REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE FINAL EVALUATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THIS REPORT INCLUDES FINAL EVALUATION FINDINGS. NO ADDITIONAL INFORMATION IS EXPECTED. EVALUATION SUMMARY: A PATIENT REPORTED THAT HIS HUMAPEN MEMOIR DEVICE WAS ONLY SHOWING PART OF THE SECOND DIGIT WHEN DIALING THE DOSE. THE ACTUAL COMPLAINT DEVICE (BATCH 0906C02, MANUFACTURED JUNE 2009) WAS RETURNED FOR INVESTIGATION. A DETAILED INVESTIGATION DETERMINED THE ROOT CAUSE IS A DEFICIENT BOND BETWEEN THE CABLE AND THE LCD GLASS. THE REPORTABLE MALFUNCTION MISSING DOSE NUMBER SEGMENTS MAY RESULT IN AN INACCURATE DOSE OF INSULIN. MALFUNCTION CONFIRMED. THE USER WOULD TYPICALLY BE AWARE OF MISSING DOSE NUMBER SEGMENTS. WHEN THE PEN IS POWERED ON, ALL SEGMENTS OF THE DISPLAY ARE ILLUMINATED TO CONFIRM PROPER FUNCTION. THE USER MANUAL INSTRUCTS THAT IF ANY PART OF THE PEN DISPLAY IS MISSING DO NOT USE PEN. IT FURTHER INSTRUCTS THAT IF THE DISPLAY IS NOT WORKING CORRECTLY TO CONTACT LILLY AT XXX-XXX-XXXX OR YOUR HEALTHCARE PROFESSIONAL. CORRECTIVE ACTION DEFICIENT BOND. A CORRECTIVE ACTION WAS IMPLEMENTED (B)(4). IMPROPER USE AND STORAGE - THERE IS NO EVIDENCE OF IMPROPER USE OR STORAGE.

    Description of Event or Problem · 1

    (B)(4). THIS DEVICE CASE, WHICH DOES NOT INVOLVE AN ADVERSE EVENT, REPORTED BY A CONSUMER WHO CONTACTED THE COMPANY TO REPORT A PRODUCT COMPLAINT, REGARDS A MALE PATIENT OF UNSPECIFIED AGE OR ORIGIN. THE PATIENT WAS TAKING INSULIN LISPRO (HUMALOG) (DOSE, INDICATION, FREQUENCY AND START DATE NOT PROVIDED). ON (B)(6) 2011, IT WAS REPORTED THAT THE PATIENT'S HUMAPEN MEMOIR DIGITS WERE NOT COMPLETE. WHEN DIALING A DOSE, THE DISPLAY DID NOT SHOW PART OF THE SECOND DIGIT. THE HUMAPEN MEMOIR WAS ASSOCIATED WITH PRODUCT COMPLAINT (B)(4). THE PATIENT WAS THE USER OF THE DEVICE. THE USER'S TRAINING STATUS WAS NOT PROVIDED. THE DURATION OF USE WAS PROVIDED AS WEEKS. RETURN STATUS OF THE PEN WAS NOT PROVIDED. UPDATE (B)(6) 2011: ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2011 FROM THE PRODUCT COMPLAINT SAFETY DATABASE. LOT NUMBER 0908C02 WAS CORRECTED TO 0906C02. UPDATED PRODUCT TAB FOR HUMAPEN MEMOIR AND UPDATED THE NARRATIVE WITH THE CHANGE.

    Description of Event or Problem · 1

    (B)(4). THIS DEVICE CASE, WHICH DOES NOT INVOLVE AN ADVERSE EVENT, REPORTED BY A CONSUMER WHO CONTACTED THE COMPANY TO REPORT A PRODUCT COMPLAINT, REGARDS A MALE PATIENT OF UNSPECIFIED AGE OR ORIGIN. THE PATIENT WAS TAKING INSULIN LISPRO (HUMALOG) (DOSE, INDICATION, FREQUENCY AND START DATE NOT PROVIDED). ON (B)(6) 2011 IT WAS REPORTED THAT THE PATIENT'S HUMAPEN MEMOIR DIGITS WERE NOT COMPLETE. WHEN DIALING A DOSE THE DISPLAY DID NOT SHOW PART OF THE SECOND DIGIT. THE HUMAPEN MEMOIR WAS ASSOCIATED WITH PRODUCT COMPLAINT (B)(4). THE PATIENT WAS THE USER OF THE DEVICE. THE USER'S TRAINING STATUS WAS NOT PROVIDED. THE DURATION OF USE WAS PROVIDED AS WEEKS. THE DEVICE WAS RETURNED ON (B)(4) 2011. UPDATE (B)(4) 2011: ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2011 FROM THE PRODUCT COMPLAINT SAFETY DATABASE. LOT NUMBER 0908C02 WAS CORRECTED TO 0906C02. UPDATED PRODUCT TAB FOR HUMAPEN MEMOIR AND UPDATED THE NARRATIVE WITH THE CHANGE. UPDATE (B)(4) 2011: ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2011 FROM THE GLOBAL PRODUCT COMPLAINT DATABASE ADDED THE DEVICE SPECIFIC SAFETY SUMMARY; ADDED THE DEVICE RETURNED DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN MEMOIR FOR TREATMENT PURPOSES NSC ELI LILLY AND COMPANY MS9660 0906C02

    Patients

    Seq Age Sex Outcome Treatment
    1 HUMALOG (INSULIN LISPRO)