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

Model Number MS9557

Device Problems Partial Blockage (1065); No Flow (2991)

Patient Problems Erythema (1840); Hypoglycemia (1912); Loss of consciousness (2418); Reaction, Injection Site (2442)

Event Date 12/08/2015

Event Type  Injury  

Manufacturer Narrative

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

(b)(4) this solicited case, reported by a consumer via patient support program (psp), concerned a (b)(6) chinese female patient.Medical history included cerebral infarction and cataract.Concomitant medications were not reported.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humulin 70/30) cartridge via reusable blue pen (unknown name), 20 units each morning and 8 units each evening, subcutaneously for the treatment of diabetes mellitus, beginning in 2011.Sometime while on treatment with human insulin isophane suspension 70%/human insulin 30%, her injection sites turned red.The treating physician believed it was not an allergic reaction but did not provide the exact cause.In 2014 her injection pen blocked but after a troubleshooting it worked well again.On (b)(6) 2015 she had hypoglycemia, her fasting blood glucose was between 1 and 2 and fainted away.On (b)(6) 2015 she went to see doctor and was hospitalized; the same day her pen was blocked again.She changed the needle every three injections and after troubleshooting insulin still did not come out from the pen ((b)(4)/lot 0409001).She remained hospitalized until (b)(6) 2015.Information regarding corrective treatment and events outcome was unknown.Human insulin isophane suspension 70%/human insulin 30% was continued.The operator of the pen and training status was unknown.The device model duration of use was approximately 5 years and the suspect pen duration of use was unknown.If the suspect device of the was returned, evaluation would be performed to determine if a malfunction had occurred.The reporting consumer did not know if the reported events were related to human insulin isophane suspension 70%/human insulin 30% or not.Update 25jan2016: upon review, this case was opened to update the medwatch fields for regulatory reporting, and to add the (b)(4) to the case.

Manufacturer Narrative

Narrative field - new, updated and corrected information is referenced within the update statements.Please refer to update statement dated 10feb2016 in the report.No further follow up is planned.Evaluation summary a female patient reported her humapen ergo ii device was "blocked" and "jammed." she experienced hypoglycemia.The device was not returned to the manufacturer for investigation (batch unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.All humapen ergo ii devices are assessed for injection screw travel at the end of the manufacturing process, which would ensure dose accuracy with high probability.The patient reported she started using her ergo ii device in 2011.The humapen ergo ii user manual states the device was designed to be used for up to 3 years after first use.The patient also reported that she only changed the needle after three injections.There is evidence of improper use.The patient used the device beyond its approved use life and reused needles.It is unknown if this is relevant to the complaint of hypoglycemia.

Event Description

(b)(4) this solicited case, reported by a consumer via patient support program (psp), concerned a (b)(6) chinese female patient.Medical history included cerebral infarction and cataract.Concomitant medications were not reported.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humulin 70/30) cartridge via reusable blue pen (humapen ergo ii), 20 units each morning and 8 units each evening, subcutaneously for the treatment of diabetes mellitus, beginning in 2011.Sometime while on treatment with human insulin isophane suspension 70%/human insulin 30%, her injection sites turned red.The treating physician believed it was not an allergic reaction but did not provide the exact cause.In 2014 her injection pen blocked but after a troubleshooting it worked well again.On (b)(6) 2015 she had hypoglycemia, her fasting blood glucose was between 1 and 2 and fainted away.On (b)(6) 2015 she went to see the doctor and was hospitalized; the same day her pen was blocked again.She changed the needle every three injections and after troubleshooting insulin still did not come out from the pen (product complaint 3541145/lot 0409001).She remained hospitalized until (b)(6) 2015.Information regarding corrective treatment and events outcome was unknown.Human insulin isophane suspension 70%/human insulin 30% was continued.The operator of the pen and training status was unknown.The device model duration of use was approximately 5 years and the suspect pen duration of use was unknown.The device was not returned.The reporting consumer did not know if the reported events were related to human insulin isophane suspension 70%/human insulin 30% or not.Follow-up is not possible since the reporter could not be contacted after several attempts for further inquiry.Update 25-jan-2016: upon review, this case was opened to update the medwatch fields for regulatory reporting, and to add the product complaint number 3541145 to the case.Edit 03-feb-2016: information was received from the affiliate on (b)(6) 2016.Several attempts were performed to contact initial reporter but no new information was obtained.Added follow-up paragraph to narrative.No other changes performed to the case.Update 10-feb-2016: additional information received on 09-feb-2016 from the global product complaint database added the device specific safety summary; updated the device to a humapen ergo ii based on color; added the device was not returned; updated the medwatch and european and canadian required device reporting elements; and updated the narrative.

• 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: 5393827
• MDR Text Key: 36927195
• Report Number: 1819470-2016-00018
• 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: 01/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 0409001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 77 YR
• Patient Weight: 45