BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN ERGO TEAL/OPAQUE

    MDR report key: 2943361 · Received February 5, 2013

    Report

    Report Number
    1819470-2013-00001
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Report Date
    January 10, 2013
    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

    NEW, UPDATED AND CORRECTED INFORMATION IS REFERENCED WITHIN THE UPDATE STATEMENTS. PLEASE REFER TO UPDATE STATEMENT DATED (B)(6) 2013. NO FURTHER FOLLOW UP IS PLANNED A PATIENT REPORTED THAT THE INJECTION SCREW OF HIS HUMAPEN ERGO WAS NOT WORKING. INVESTIGATION OF THE RETURNED DEVICE (BATCH A1445, MANUFACTURED FEBRUARY 2000) DETERMINED THE DEVICE IS BEYOND ITS USABLE LIFE AND FOUND BOTH OPAQUE CARTRIDGE HOLDER ENGAGEMENT TABS WERE BROKEN. THIS MALFUNCTION MAY CAUSE AN UNDERDOSE. CORRECTIVE ACTION: A NEW CARTRIDGE HOLDER DESIGN WAS DEVELOPED AND INTRODUCED IN SEPTEMBER 2000 WITH LOT A1493. THIS DESIGN ELIMINATES STRESS ON THE ENGAGEMENT TABS AND ANY UNDESIRABLE SURFACE FEATURES. NO FURTHER CORRECTIVE ACTIONS ARE PLANNED AS THE DEVICE MANUFACTURING WAS DISCONTINUED DECEMBER 2006. IMPROPER USE AND STORAGE - THERE IS EVIDENCE OF IMPROPER USE. THE PATIENT REUSED NEEDLES, HOWEVER, THIS MAY NOT BE RELEVANT TO THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    NO FURTHER FOLLOW UP IS PLANNED. EVALUATION SUMMARY A PATIENT REPORTED THAT THE INJECTION SCREW OF HIS HUMAPEN ERGO WAS NOT WORKING. INVESTIGATION OF THE RETURNED DEVICE (BATCH A1445, MANUFACTURED FEBRUARY 2000) DETERMINED THE DEVICE IS BEYOND ITS USABLE LIFE AND FOUND BOTH OPAQUE CARTRIDGE HOLDER ENGAGEMENT TABS WERE BROKEN. THIS MALFUNCTION MAY CAUSE AN UNDERDOSE. CORRECTIVE ACTION: (B)(4). IMPROPER USE AND STORAGE - THERE IS EVIDENCE OF IMPROPER USE. THE PATIENT REUSED NEEDLES, HOWEVER THIS MAY NOT BE RELEVANT TO THIS COMPLAINT.

    Description of Event or Problem · 1

    LILLY CASE ID: (B)(6) 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 AN UNSPECIFIED MEDICATION FOR TREATMENT OF AN UNKNOWN INDICATION. ON (B)(6) 2012, THE HUMAPEN ERGO TEAL/OPAQUE PEN BODY WITH A CLEAR CARTRIDGE HOLDER ATTACHED WAS REPORTED TO HAVE AN INJECTION SCREW THAT WAS NOT WORKING. HE REPORTED THAT THE INJECTION SCREW WAS NOT LEAVING THE DEVICE WHEN THE INJECTION BUTTON WAS PUSHED. THIS HUMAPEN ERGO TEAL/OPAQUE PEN BODY WITH A CLEAR CARTRIDGE HOLDER ATTACHED WAS ASSOCIATED WITH PRODUCT COMPLAINT 2439152, LOT A1445 MANUFACTURED 20-FEB-2000. THE PATIENT DID REUSE NEEDLES. THE RETURNED DEVICE WAS FOUND TO HAVE TWO BROKEN OPAGUE CARTRIDGE HOLDER ENGAGEMENT TABS. THE PATIENT WAS THE OPERATOR OF THE DEVICE, AND WAS TRAINED BY A PHYSICIAN. GENERAL AND SUSPECT DEVICE DURATION OF USE WAS NOT PROVIDED, BUT WAS DESCRIBED AS A LONG PERIOD OF TIME. THE DEVICE WAS RETURNED ON (B)(4) 2013. THE HUMAPEN ERGO TEAL/OPAQUE PEN BODY WITH A CLEAR CARTRIDGE HOLDER ATTACHED WAS NOT CONTINUED. UPDATE (B)(6) 2013: ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2013, FROM THE PRODUCT COMPLAINT SAFETY DATABASE. ADDED THE DEVICE SPECIFIC SAFETY SUMMARY, AND THE SUSPECT DEVICE MANUFACTURER DATE. UPDATED THE MEDWATCH INFORMATION, (B)(4) FIELDS . NARRATIVE UPDATED ACCORDINGLY.

    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 AN UNSPECIFIED MEDICATION FOR TREATMENT OF AN UNKNOWN INDICATION. ON (B)(6) 2012, THE HUMAPEN ERGO TEAL/OPAQUE PEN BODY WAS REPORTED TO HAVE AN INJECTION SCREW THAT WAS NOT WORKING. HE REPORTED THAT THE INJECTION SCREW WAS NOT LEAVING THE DEVICE WHEN THE INJECTION BUTTON WAS PUSHED. THIS HUMAPEN ERGO TEAL/OPAQUE PEN BODY WAS ASSOCIATED WITH PRODUCT COMPLAINT 2439152, LOT A1445 MANUFACTURED 20-FEB-2000. THE PATIENT DID REUSE NEEDLES. THE RETURNED DEVICE WAS FOUND TO HAVE TWO BROKEN OPAQUE CARTRIDGE HOLDER ENGAGEMENT TABS. THE PATIENT WAS THE OPERATOR OF THE DEVICE, AND WAS TRAINED BY A PHYSICIAN. GENERAL AND SUSPECT DEVICE DURATION OF USE WAS NOT PROVIDED, BUT WAS DESCRIBED AS A LONG PERIOD OF TIME. THE DEVICE WAS RETURNED ON (B)(4) 2013. THE HUMAPEN ERGO TEAL/OPAQUE PEN BODY WAS NOT CONTINUED. UPDATE (B)(6) 2013: ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2013 FROM THE PRODUCT COMPLAINT SAFETY DATABASE. ADDED THE DEVICE SPECIFIC SAFETY SUMMARY, AND THE SUSPECT DEVICE MANUFACTURER DATE. UPDATED THE MEDWATCH INFORMATION, EU/CA FIELDS . NARRATIVE UPDATED ACCORDINGLY. UPDATE (B)(6) 2013: ADDITIONAL INFORMATION WAS RECEIVED FROM THE PRODUCT COMPLAINT SAFETY DATABASE ON (B)(6) 2013. CAPTURED THE DEVICE ERGO TEAL/OPAQUE PEN BODY WITH CLEAR CARTRIDGE HOLDER ATTACHED AS ACTUAL ERGO TEAL/OPAQUE PEN. UPDATED NARRATIVE TO INCLUDE NEW DEVICE INFORMATION. UPDATE (B)(6) 2013: UPON REVIEW OF THIS CASE, THE INCORRECT FOLLOW UP DATE OF (B)(6) 2013 WAS ENTERED IN THE CASE. CORRECTED FOLLOW UP DATE OF (B)(6) 2013 WAS ADDED TO THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49412 HUMAPEN ERGO TEAL/OPAQUE FOR TREATMENT PURPOSES NSC ELI LILLY AND COMPANY MS8335 A1445

    Patients

    Seq Age Sex Outcome Treatment
    1