BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN ERGO TEAL/CLEAR

    MDR report key: 3121543 · Received May 21, 2013

    Report

    Report Number
    1819470-2013-00020
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    April 30, 2013
    Manufacturer
    ELI LILLY AND COMPANY
    Product Code
    NSC
    PMA / PMN Number
    K982842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTABLE MALFUNCTION/INCIDENT IDENTIFIED. INVESTIGATION IN PROGRESS. THIS IS AN INITIAL REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE FINAL EVALUATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: A PATIENT REPORTED THAT THE ENGAGEMENT TABS OF THEIR HUMAPEN ERGO DEVICE WERE BROKEN. INVESTIGATION OF THE RETURNED DEVICE (BATCH 0607A02, MANUFACTURED JULY 2006) FOUND THE CARTRIDGE HOLDER ENGAGEMENT TABS WERE PRESENT AND INTACT. THE REPORTABLE MALFUNCTION OF A CARTRIDGE HOLDER TWO TAB BREAKAGE WAS NOT CONFIRMED. NO MALFUNCTION WAS IDENTIFIED. IMPROPER USE AND STORAGE - THERE IS NO EVIDENCE OF IMPROPER USE OR STORAGE.

    Description of Event or Problem · 1

    LILLY CASE ID: (B)(4). THIS DEVICE CASE, WHICH DOES NOT INVOLVE AN ADVERSE EVENT, REPORTED BY A CONSUMER, WHO CONTACTED THE COMPANY WITH A PRODUCT COMPLAINT, CONCERNS A PATIENT OF UNKNOWN AGE, GENDER, OR ORIGIN. THE PATIENT WAS TAKING AN UNSPECIFIED MEDICATION FOR TREATMENT OF AN UNKNOWN INDICATION. ON (B)(6) 2013, THE HUMAPEN ERGO TEAL/CLEAR PEN BODY WITH A CLEAR CARTRIDGE HOLDER WAS RETURNED TO THE COMPANY. THIS HUMAPEN ERGO, TEAL/CLEAR PEN BODY WITH A CLEAR CARTRIDGE HOLDER ATTACHED WAS ASSOCIATED WITH PRODUCT COMPLAINT (B)(4), LOT 0607A02. THE RETURNED DEVICE WAS FOUND TO HAVE TWO BROKEN CLEAR CARTRIDGE HOLDER (CCH) ENGAGEMENT TABS. THE OPERATOR OF THE DEVICE WAS UNKNOWN. IT WAS UNKNOWN IF THE USER WAS TRAINED. THIS DEVICE MODEL WAS USED FOR AN UNSPECIFIED LENGTH OF TIME. THE DEVICE WAS RETURNED ON (B)(4) 2013. THE HUMAPEN ERGO TEAL/CLEAR PEN BODY WITH CLEAR CARTRIDGE HOLDER ATTACHED WAS NOT CONTINUED.

    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 WITH A PRODUCT COMPLAINT, CONCERNS A PATIENT OF UNKNOWN AGE, GENDER, OR ORIGIN. THE PATIENT WAS TAKING AN UNSPECIFIED MEDICATION FOR TREATMENT OF AN UNKNOWN INDICATION. ON (B)(6) 2013, THE HUMAPEN ERGO TEAL/CLEAR PEN BODY WITH A CLEAR CARTRIDGE HOLDER WAS RETURNED TO THE COMPANY. THIS HUMAPEN ERGO, TEAL/CLEAR PEN BODY WITH A CLEAR CARTRIDGE HOLDER ATTACHED WAS ASSOCIATED WITH PRODUCT COMPLAINT (B)(4), LOT 0607A02, MANUFACTURE DATE JULY 2006. PRODUCT MET PERFORMANCE SPECIFICATION. NO MALFUNCTION IDENTIFIED. THERE WAS NO EVIDENCE OF IMPROPER USE OR STORAGE. THE OPERATOR OF THE DEVICE WAS UNKNOWN. IT WAS UNKNOWN IF THE USER WAS TRAINED. THIS DEVICE MODEL WAS USED FOR AN UNSPECIFIED LENGTH OF TIME. THE DEVICE WAS RETURNED ON 30APR2013. THE HUMAPEN ERGO TEAL/CLEAR PEN BODY WITH CLEAR CARTRIDGE HOLDER ATTACHED WAS NOT CONTINUED. UPDATE 20JUN2013. INFORMATION RECEIVED 19JUN2013 FROM THE GLOBAL PRODUCT COMPLAINT DATABASE DID NOT CONTAIN ANY NEW INFORMATION. UPDATE 24JUN2013. ADDITIONAL INFORMATION RECEIVED 21JUN2013 FROM THE GLOBAL PRODUCT COMPLAINT DATABASE. ADDED THE DEVICE SPECIFIC SAFETY SUMMARY, MANUFACTURE DATE, CHANGED MALFUNCTION TO NO, ON THE DEVICE PAGE UPDATED THE EU/CA FIELDS, MEDWATCH FIELDS, AND UPDATED THE NARRATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224125 HUMAPEN ERGO TEAL/CLEAR FOR TREATMENT PURPOSES NSC ELI LILLY AND COMPANY MS8929 0607A02

    Patients

    Seq Age Sex Outcome Treatment
    1