BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN ERGO, TEAL/CLEAR

    MDR report key: 1851149 · Received October 4, 2010

    Report

    Report Number
    1819470-2010-00076
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Report Date
    September 21, 2010
    Manufacturer
    ELI LILLY AND COMPANY
    Product Code
    NSC
    PMA / PMN Number
    K982842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT INCLUDES FINAL EVALUATION FINDINGS. NO ADDITIONAL INFORMATION IS EXPECTED. EVALUATION SUMMARY THE USER RETURNED THE ACTUAL COMPLAINT DEVICE WITH A CLEAR CARTRIDGE HOLDER ATTACHED FOR INVESTIGATION (LOT 40289, MANUFACTURED DECEMBER 2002). THE USER REPORTED THAT BOTH ENGAGEMENT TABS WERE BROKEN. HOWEVER, THE MANUFACTURER'S INVESTIGATION DOES NOT SUPPORT THIS FINDING AS BOTH ENGAGEMENT TABS WERE INTACT. BOTH SPRING ARMS, HOWEVER, WERE BROKEN. THE DEVICE WAS TESTED AND MET ALL FUNCTIONAL REQUIREMENTS AND DOSE ACCURACY AND GLIDE FORCE ACCEPTANCE CRITERIA. NO MALFUNCTION WAS IDENTIFIED. THERE IS EVIDENCE OF IMPROPER USE. THE USER STATED THAT HE ALLOWED SOMEONE ELSE TO USE HIS PEN. THE ERGO USER MANUAL STATES 'DO NOT SHARE YOUR PEN AND NEEDLES.' ALSO, THE USER REUSES NEEDLES. NEEDLE REUSE CAN RESULT IN AN UNDERDOSE. HOWEVER, THESE MISUSES ARE NOT RELEVANT TO THE USER'S COMPLAINT.

    Additional Manufacturer Narrative · 1

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

    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 MALE PATIENT OF UNKNOWN AGE OR ORIGIN. THE PATIENT WAS TAKING INSULIN LISPRO (HUMALOG) FOR TREATMENT OF AN UNKNOWN INDICATION. ON (B)(6) 2010, THE HUMAPEN ERGO TEAL BODY WITH CLEAR CARTRIDGE HOLDER ATTACHED WAS REPORTED TO HAVE BOTH CARTRIDGE HOLDER ENGAGEMENT TABS BROKEN MAKING IT DIFFICULT TO APPLY THE INSULIN BECAUSE THE CARTRIDGE HOLDER DID NOT ATTACH TO THE PEN BODY. THE HUMAPEN ERGO WAS USED WITH THE BROKEN ENGAGEMENT TABS FOR TWO MONTHS. HUMAPEN ERGO TEAL BODY WITH CLEAR CARTRIDGE WAS ASSOCIATED WITH PRODUCT COMPLAINT (B)(4), LOT 40289. THE OPERATOR OF THE DEVICE WAS THE PATIENT. THE USER WAS TRAINED VIA A SALES REPRESENTATIVE. THIS DEVICE MODEL WAS USED FOR AN UNSPECIFIED LENGTH OF TIME THAT WAS REPORTED AS MANY YEARS. THE DEVICE WAS RETURNED TO THE MANUFACTURER. THE USER REUSES NEEDLES AND SHARED HIS PEN WITH ANOTHER USER. UPDATE 07-OCT-2010: ADDITIONAL INFORMATION RECEIVED ON 05-OCT-2010 FROM THE GLOBAL PRODUCT COMPLAINT DATABASE UPDATED THE DEVICE FROM UNKNOWN BODY TYPE TO TEAL; UPDATED THE LOT NUMBER FROM UNKNOWN TO 40289; AND UPDATED THE NARRATIVE. UPDATE 19-OCT-2010: ADDITIONAL INFORMATION RECEIVED 19-OCT-2010 VIA GLOBAL PRODUCT COMPLAINT DATABASE. ADDED DEVICE SPECIFIC SAFETY SUMMARY, CHANGED MALFUNCTION TO NO. AMENDED NARRATIVE AND EU/CA FIELDS.

    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 MALE PATIENT OF UNKNOWN AGE OR ORIGIN. THE PATIENT WAS TAKING INSULIN LISPRO (HUMALOG) FOR TREATMENT OF AN UNKNOWN INDICATION. ON (B)(6) 2010, THE HUMAPEN ERGO, UNKNOWN PEN BODY TYPE WAS REPORTED TO HAVE BOTH CARTRIDGE HOLDER ENGAGEMENT TABS BROKEN MAKING IT DIFFICULT TO APPLY THE INSULIN BECAUSE THE CARTRIDGE HOLDER DID NOT ATTACH TO THE PEN BODY. THE HUMAPEN ERGO WAS USED WITH THE BROKEN ENGAGEMENT TABS FOR TWO MONTHS. THIS HUMAPEN UNKNOWN PEN BODY TYPE WAS ASSOCIATED WITH PRODUCT COMPLAINT (B)(4), LOT UNKNOWN. THE OPERATOR OF THE DEVICE WAS THE PATIENT. THE USER WAS TRAINED VIA A SALES REPRESENTATIVE. THIS DEVICE MODEL WAS USED FOR AN UNSPECIFIED LENGTH OF TIME THAT WAS REPORTED AS MANY YEARS. THE DEVICE WAS BEING RETURNED. THE HUMAPEN ERGO TEAL PEN BODY WITH A CLEAR CARTRIDGE HOLDER ATTACHED WAS NOT CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO, TEAL/CLEAR PEN INJECTOR FOR TREATMENT PURPOSES NSC ELI LILLY AND COMPANY MS8929 40289

    Patients

    Seq Age Sex Outcome Treatment
    1 HUMALOG| HUMALOG