MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN ERGO II; FOR TREATMENT PURPOSES

Model Number MS9557

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908)

Event Date 03/20/2016

Event Type  Injury  

Manufacturer Narrative

Product complaint: pending.If device is returned, evaluation will be performed to determine if a malfunction has occurred.This is an initial report.A follow-up report will be submitted when the final evaluation is completed.

Event Description

Lilly case id: (b)(4) this report is associated with product complaint: pending this solicited case, reported by a consumer via a patient support program (psp), concerns a (b)(6) female patient of unspecified age.Medical history included hypertension.She was not taking any concomitant medication.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) cartridge (humulin 70/30) via a reusable pen (humapen unknown type), 20 units at morning and 10 units at night, subcutaneously, for the treatment of diabetes mellitus, beginning in 2011.On unspecified date, her control of blood glucose was not good and she had unspecified complications.Her physician changed human isophane suspension 70%/human insulin 30% to unspecified brand insulin.On unspecified date, by physician order changed back to human isophane suspension 70%/human insulin 30%.On (b)(6) 2016, she experienced hyperglycemia (unspecified values) and was hospitalized.No further information regarding hospitalization was provided.Information regarding corrective treatments was not provided.She had unspecified problems with the unknown humapen (product complaint pending/lot unknown).The outcomes of the events were unknown.Human insulin isophane suspension 70%/human insulin 30% treatment was continued.The operator of the device and training status were not provided.The general device and the suspect device duration of use were not provided.If device was returned, evaluation would be performed.The reporting consumer did not know if the events were related to human isophane suspension 70%/human insulin 30% treatment.An opinion of relatedness was not provided for the device or the unspecified brand of insulin.Update 01apr2016: upon review, this case was opened to update the medwatch and (b)(4) required device reporting elements for regulatory reporting; and the product complaint information was added to the narrative.

Manufacturer Narrative

No further follow-up is planned.Evaluation summary: a female patient reported the cartridge holder on her humapen ergo ii device would not connect to the body of the device.She experienced hyperglycemia.Investigation of the returned device (batch 0903d01, manufactured march 2009) found the thread end of the cartridge holder was cracked and there were miniscule cracks (crazing) on the surface of the holder.The threads on the cartridge holder had foreign material on them which prevented it from attaching to the front housing threads normally; the cartridge holder had a gritty and tight attachment.The foreign material on the threads was not related to the manufacturing process.The surface cracks were consistent with the cartridge holder being exposed to an unknown chemical while in the field and the crack in the thread end was consistent with excessive force being applied to the cartridge holder.Additionally, the injection foot was found to be detached and not returned with the device.The detachment of the foot was attributed to damage while in the field and supported by evidence of unknown tool marks present on the tip of the injection screw.Although the foot was missing, the device did meet functional requirements.No malfunction was identified.It has been demonstrated that humapen ergo ii devices remain dose accurate with a detached foot.The user manual describes the proper care and storage of the device.It instructs the user not to use alcohol, hydrogen peroxide, bleach, cover in liquid, apply lubrication such as oil, or get food, drink or other materials in the pen as this could damage the pen.There is evidence of improper use.The cartridge holder had foreign material on the threads, was exposed to an unknown chemical and was subjected to excessive force while in the field.It is unknown if this is relevant to the complaint of hyperglycemia.

Event Description

Lilly case id: (b)(6).This report is associated with product complaint: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerns a chinese female patient of unspecified age.Medical history included hypertension.She was not taking any concomitant medication.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) cartridge (humulin 70/30) via a reusable pen (humapen ergo ii), 20 units at morning and 10 units at night, subcutaneously, for the treatment of diabetes mellitus, beginning in 2011.On unspecified date, her control of blood glucose was not good and she had unspecified complications.Her physician changed human isophane suspension 70%/human insulin 30% to unspecified brand insulin.On unspecified date, by physician order changed back to human isophane suspension 70%/human insulin 30%.On (b)(6) 2016, she experienced hyperglycemia (unspecified values) and was hospitalized.No further information regarding hospitalization was provided.Information regarding corrective treatments was not provided.She had unspecified problems with the humapen ergo ii (product complaint (b)(4)/lot 3618169/lot 0903d01).The outcomes of the events were unknown.Human insulin isophane suspension 70%/human insulin 30% treatment was continued.The operator of the device and training status were not provided.The manufacture date was 31amar2009, approximate age of the device was 7 years.The device was returned on 07-apr-2016.There was indication of improper use: the cartridge holder had foreign material on the threads, was exposed to an unknown chemical and was subjected to excessive force while in the field.Update 31may2016.Additional information received 31may2016 from the product complaint safety database.To the device tab added manufacture date, approximate device age, changed improper use to yes, malfunction to no, added the device specific safety summary (dsss),updated the european and (b)(4) device information, entered the device medwatch information, and the narrative was updated accordingly.The reporting consumer did not know if the events were related to human isophane suspension 70%/human insulin 30% treatment.An opinion of relatedness was not provided for the device or the unspecified brand of insulin.Update 01-apr-2016: upon review, this case was opened to update the medwatch and european and canadian required device reporting elements for regulatory reporting; and the product complaint information was added to the narrative.Update 11-apr-2016: additional information received on 10-apr-2016 from global product complaint database updated the lot number from unknown to 0903d01 for product complaint (b)(4) which updated the device to a humapen ergo ii.The european and (b)(4) required device reporting elements were updated.The return date of the device was added.The product tab for humapen ergo ii and the narrative were updated.Edit 14-apr-2016.Information received on 29-mar-2016 in which product complaint was confirmed.No additional information was added to case.Update 31may2016.Additional information received 31may2016 from the product complaint safety database.To the device tab added manufacture date, approximate device age, changed improper use to yes, malfunction to no, added the device specific safety summary (dsss), updated the european and (b)(4) device information, updated the device medwatch information, and the narrative was updated accordingly.

• Brand Name: HUMAPEN ERGO II
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer (Section G): PHILLIPS-MEDISIZE CORPORATION; 415 red cedar street; medical device manufacturing; menomonie WI 54751
• Manufacturer Contact: caroline rosewell ; lilly corporate center; indianapolis, IN 46285 ; 3172764376
• MDR Report Key: 5543906
• MDR Text Key: 41763637
• Report Number: 1819470-2016-00083
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K151686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 03/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 0903D01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2016
• Date Manufacturer Received: 05/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 55