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 Eye Injury (1845); Hemorrhage/Bleeding (1888)

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 report will be submitted when the final evaluation has been completed.

Event Description

(b)(4).This spontaneous case, reported by a consumer who contacted the company to report an adverse event, concerned a (b)(6) female patient.Medical history included hypertension and legs pain caused by leg neuropathy.Concomitant medications included beta carotene / vaccinum myttillus for unknown indication, and unspecified hypotensive drugs.The patient received insulin lispro protamine suspension 50%/ insulin lispro 50% (rdna origin) via reusable pen (humapen ergo ii) (humalog mix50) twice daily, 30 units in the morning and 20 units in the evening, subcutaneously for the treatment of diabetes beginning in 2014 (or 2015, conflicting information).In 2015, while on insulin lispro protamine suspension 50%/ insulin lispro 50%, she experienced symptom of fundus hemorrhage, maculopathy and high urine protein (no values provided).On unknown date while on treatment, she had high blood sugar (no values provided) and on (b)(6) 2016, she was hospitalized to regulate them (lot number 1010d02, product complaint number pending).On unknown date, during hospitalization, she had a cold.No end date of hospitalization was provided.Information regarding corrective treatments and outcome of the events was not provided.Insulin lispro protamine suspension 50%/ insulin lispro 50% was continued.The user of the humapen ergo ii and their training status was not provided.The humapen ergo ii model and suspect humapen ergo ii durations of use were not provided.The humapen ergo ii was stopped on (b)(6) 2016.The reporting consumer did not know if the events were related to insulin lispro protamine suspension 50%/ insulin lispro 50% and did not provide a relatedness assessment between the events and the humapen ergo ii.Update 08dec2016: upon review, this case was opened to update the medwatch and european and canadian required device reporting elements for regulatory reporting.

Manufacturer Narrative

Narrative field - new, updated and corrected information is referenced within the update statements in describe event or problem.Please refer to update statement dated 09jan2017 in describe event or problem.No further follow up is planned.Evaluation summary: a female patient reported that the foot of the injection screw on her humapen ergo ii device could not be pushed back in to the device.She experienced increased blood glucose levels.The investigation of the returned device (batch (b)(4), manufactured october 2010) found that the injection screw appeared normal and was not stuck.No malfunction was identified.However, additional functional and dose accuracy testing of the device could not be performed since the barrel and housing of the device were damaged and had stress marks.The damage was consistent with excessive force being applied to the device while in the field.Malfunction confirmed for the damage to the barrel and housing.General handling instructions are provided in the instructions for use.There is evidence of improper use.The barrel and housing of the device were damaged as evidenced by stress marks on the device.It is unknown if this is relevant to the event of increased blood glucose levels.

Event Description

(b)(4).This spontaneous case, reported by a consumer who contacted the company to report an adverse event, with additional information from the initial reporter, concerned a (b)(6) female patient.Medical history included hypertension and legs pain caused by leg neuropathy.Concomitant medications included beta carotene / vaccinum myrtillus for unknown indication, and unspecified hypotensive drugs.The patient received insulin lispro protamine suspension 50%/ insulin lispro 50% (rdna origin) through a cartridge via reusable pen (humapen ergo ii) (humalog mix50) twice daily, 30 units in the morning and 20 units in the evening, subcutaneously for the treatment of diabetes beginning in 2014 (or 2015, conflicting information).In 2015, while on insulin lispro protamine suspension 50%/ insulin lispro 50%, she experienced symptom of fundus hemorrhage of the eye, maculopathy and high urine protein (no values provided).The event of fundus hemorrhage of the eye was considered serious due to its medical significance.On unknown date while on treatment, she had high blood sugar (no values provided) and on (b)(6) 2016, she was hospitalized to regulate them (lot number 1010d02, (b)(4)).On unknown date, during hospitalization, she had a cold.No end date of hospitalization was provided.Information regarding corrective treatments and outcome of the events was not provided.Insulin lispro protamine suspension 50%/ insulin lispro 50% was continued.The user of the humapen ergo ii and their training status was not provided.The humapen ergo ii model and suspect humapen ergo ii durations of use were not provided.The humapen ergo ii was returned on 09dec2016.The reporting consumer did not know if the events were related to insulin lispro protamine suspension 50%/ insulin lispro 50% and did not provide a relatedness assessment between the events and the humapen ergo ii.Update 08dec2016: upon review, this case was opened to update the medwatch and european and canadian required device reporting elements for regulatory reporting.Update 12-dec-2016: additional information was received from the initial consumer on 08-dec-2016.Fundus hemorrhage of the eye was confirmed; therefore the event was upgraded to serious, updated description as reported.Updated narrative accordingly.Edit 14-dec-2016: additional information received from internal communication on 13-dec-2016.Product complaint reference ((b)(4)) number was processed and added to narrative accordingly.No other changes were added.Edit 15-dec-2016: additional information received from internal communication on 05-dec-2016.(b)(4) was already processed.No changes were made to the case.Update 09jan2017: additional information received on 09jan2017 from the global product complaint database added the device specific safety summary, manufactured date of the device, and return date of the device; updated the improper use and storage to yes; updated the malfunction field to yes/not cirm; 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: 6158793
• MDR Text Key: 62123087
• Report Number: 1819470-2016-00327
• 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: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 1010D02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2016
• Date Manufacturer Received: 01/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2010
• 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
• Treatment: DIFRAREL; HUMALOG
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR
• Patient Weight: 64