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

Model Number MS9557

Device Problem Break (1069)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Sweating (2444)

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 a patient support program (psp), concerned a (b)(6) male patient.Medical history was not provided.Concomitant medications included an unspecified medication reported as kaboping.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) (humalog mix50) injections from a cartridge via a reusable pen (humapen ergo ii), 14 unspecified units in the morning, 6 unspecified units at noon and 12 unspecified units in the evening subcutaneously for the treatment of diabetes, beginning on (b)(6) 2014.Sometime in 2014, he got the eli-lilly injection pen gave by (b)(6).On an unspecified date, after he started using insulin lispro protamine suspension 50%/insulin lispro 50%, he had the symptom of high blood sugar (no values, reference values or details were provided).Physician let him adjusted dosage to 16 unspecified units in the morning, 6 to 7 unspecified units at noon, and 14 unspecified units in the evening.Then, physician changed dosage to 18 unspecified units in the morning, 7 unspecified units at noon, and 16 unspecified units in the evening.The last change of dosage was 20 unspecified units in the morning, 8 unspecified units at noon, and 18 unspecified units in the evening.On an unknown date, he was hospitalized twice to adjust blood sugar.No more details regarding admission and discharge dates as well as treatment and laboratory tests done while hospitalized were provided.On another unspecified date, if he ate less in the morning, he would have hypoglycemia before noon with shivered convulsively, at the moment nigrescent and sweating.These symptoms were relieved after eating some food.On (b)(6) 2016 was the last time with hypoglycemia.At that time, the symptom relieved after eating some fruit drops.Also, the front of injection pen was broken down and could not install syringe needle.On that same date, he changed a new injection pen in (b)(6).Information regarding additional corrective treatment and outcome of the remaining events was not provided.Insulin lispro protamine suspension 50%/insulin lispro 50% treatment was continued.The operator of the device and his or her training status was not provided.The device model duration of use was since 2014.The reported device duration of use was not provided.If device would be returned, an evaluation would be performed to determine if a malfunction has occurred.The consumer reporter did not know if the events were related the insulin lispro protamine suspension 50%/insulin lispro 50% therapy but did not provide a relatedness assessment between them and device.Edit 23may2016.Case was opened to enter medwatch device fields for device mailing.No new information.Edit 23-may-2016: upon internal review, the case was reopened in order to adding missing product complaint information to the narrative.No additional information was added to the case.

Manufacturer Narrative

No further follow up is planned evaluation summary: a male patient reported that the front of his humapen ergo ii device was broken down and he could not install the needle.He experienced abnormal blood glucose levels.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.There is no evidence of improper use or storage.

Event Description

(b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) male patient.Medical history was not provided.Concomitant medications included an unspecified medication reported as kaboping.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) (humalog mix50) injections from a cartridge via a reusable pen (humapen ergo ii), 14 unspecified units in the morning, 6 unspecified units at noon and 12 unspecified units in the evening subcutaneously for the treatment of diabetes, beginning on (b)(6) 2014.Sometime in 2014, he got the eli-lilly injection pen gave by (b)(6).On an unspecified date, after he started using insulin lispro protamine suspension 50%/insulin lispro 50%, he had the symptom of high blood sugar (no values, reference values or details were provided).Physician let him adjusted dosage to 16 unspecified units in the morning, 6 to 7 unspecified units at noon, and 14 unspecified units in the evening.Then, physician changed dosage to 18 unspecified units in the morning, 7 unspecified units at noon, and 16 unspecified units in the evening.The last change of dosage was 20 unspecified units in the morning, 8 unspecified units at noon, and 18 unspecified units in the evening.On an unknown date, he was hospitalized twice to adjust blood sugar.No more details regarding admission and discharge dates as well as treatment and laboratory tests done while hospitalized were provided.On another unspecified date, if he ate less in the morning, he would have hypoglycemia before noon with shivered convulsively, at the moment nigrescent and sweating.These symptoms were relieved after eating some food.On (b)(6) 2016 was the last time with hypoglycemia.At that time, the symptom relieved after eating some fruit drops.Also, the front of injection pen was broken down and could not install syringe needle (pc number (b)(4), lot number unknown).On that same date, he changed a new injection pen in (b)(6).Information regarding additional corrective treatment and outcome of the remaining events was not provided.Insulin lispro protamine suspension 50%/insulin lispro 50% treatment was continued.The operator of the device and his or her training status was not provided.The device model duration of use was since 2014.The reported device duration of use was not provided.The device was not returned.The consumer reporter did not know if the events were related the insulin lispro protamine suspension 50%/insulin lispro 50% therapy but did not provide a relatedness assessment between them and device.Edit 23may2016.Case was opened to enter medwatch device fields for device mailing.No new information.Edit 23-may-2016: upon internal review, the case was reopened in order to adding missing product complaint information to the narrative.No additional information was added to the case.Update 15-jun-2016: information regarding the pc number received on 19-may-2016 was already processed.No changes were performed in the case update 24-jun-2016: additional information received on 23-jun-2016 from the global product complaint database added the device specific safety summary; 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: 5681277
• MDR Text Key: 45972326
• Report Number: 1819470-2016-00135
• 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: 05/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MS9557
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/09/2016
• Initial Date FDA Received: 05/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 62 YR