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

Model Number MS9557

Device Problem Insufficient Information (3190)

Patient Problems Hearing Loss (1882); Hyperglycemia (1905); Hypoglycemia (1912); Ambulation Difficulties (2544)

Event Date 11/30/2015

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

Lilly case id: (b)(4) this report is associated with product complaint: (b)(4).This solicited case, reported by a consumer via a patient support program, concerns a (b)(6) year-old male patient.Medical history included high blood pressure, kidney was bad, high urine protein, blood vessel aging, spotted, retinal hemorrhage, hands and feet numbness, allergy to medication described as sulfa, high urine protein after using metformin, and swollen foot (unspecified).Concomitant medications included mecobalamin, gliquidone, pioglitazone hydrochloride, a medication described as pancreatic excitation peptide, nifedipine, berberine, beraprost sodium; all for unknown indication and unknown long-acting insulin for diabetes.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30), from cartridge, via a reusable pen (humapen ergo ll), 6 units in the morning, 8 units at night (twice a day), subcutaneously for the treatment of diabetes mellitus beginning in 2009.In 2014, approximately five years after starting human insulin 70/30 therapy, he had right ear deafness caused by diabetes lesions.Additionally, his eyes were bad and he was not able to walk.The events of right ear deafness and not able to walk were considered serious due to medically significance.On an unknown date, he developed insulin antibodies and the doctor discontinued human insulin 70/30 treatment around 2013 or 2014.At the end of (b)(6) 2015, during humapen ergo ll use, he experienced high blood sugar (unknown values) and was hospitalized.During hospitalization, in (b)(6) 2015, he received unknown long-acting insulin before sleep and had a low blood sugar at night, his blood sugar was 3-4 (units were not provided).Physician helped him to adjust the dose from 14 units to 8 units, but still experienced symptoms of hypoglycemia.Early (b)(6) 2015, he was discharged from hospital.After discharge he discontinued the unknown long-acting insulin.He was hospitalized every year for unknown reason, no more details were provided.On (b)(6) 2016, he developed high blood sugar and was hospitalized, he was discharged from hospital on (b)(6) 2016, and his doctor restarted human insulin 70/30 therapy.In (b)(6) 2016 humapen ergo ll pen had an unspecified problem (product complaint 3623281/ lot 0810d01).As of (b)(6) 2016, his postprandial blood glucose (2hrs after meal) was 12.7, no fasting glucose measurement was provided.Information regarding hospitalization details, corrective treatment and outcome of the remaining events was not provided.Human insulin isophane suspension 70%/human insulin 30% therapy was continued.The user of the humapen ergo ll and his or her training status was provided.The humapen ergo ll model was used since 2009 to (b)(6) 2016 and reported humapen ergo ll duration of use was not reported.If humapen ergo ll was returned, evaluation would be performed.The reporting consumer did not know if the events were related to the treatment to human insulin isophane suspension 70%/human insulin 30% and humapen ergo ll pen.Update 06apr2016: upon review, the case was opened to add the product complaint number to the narrative, and update the medwatch and (b)(4) required device reporting elements for regulatory reporting.

Manufacturer Narrative

New, updated and corrected information is referenced within the update statements no further follow up is planned.Evaluation summary in (b)(6) 2015 the patient experienced a serious adverse event of increased blood glucose and a second time in (b)(6) 2016.The patient reported in (b)(6) 2016 the injection screw on his humapen ergo ii device would not move out.The device was not returned to the manufacturer for investigation (batch (b)(4), manufactured october 2008).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review of the batch did not identify any atypical trends with regard to injection screw/ratchet not moving or dose accuracy.All humapen ergo ii devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring dose accuracy and device functionality with a high probability.The patient stated he had used the humapen ergo ii device since 2009.The humapen ergo ii user manual states the device was designed to be used for up to 3 years after first use.The reported increase in blood glucose in (b)(6) 2015 does not appear to be related to the injection screw problem reported in (b)(6) 2016.However, the timing of the second reported increased blood glucose in (b)(6) 2016 was in close proximity to the injection screw problem.There is evidence of improper use.The patient used the device beyond its approved use life.It is unknown if this is relevant to the complaint of increased or decreased blood glucose.

Event Description

(b)(4).This solicited case, reported by a consumer via a patient support program (psp), with additional information from the initial reporter via psp, concerned a (b)(6) chinese male patient.Medical history included high blood pressure, kidney was bad, high urine protein, blood vessel aging, spotted, retinal hemorrhage, hands and feet numbness, allergy to medication described as sulfa, high urine protein after using metformin, and swollen foot (unspecified).Concomitant medications included mecobalamin, gliquidone, pioglitazone hydrochloride, a medication described as pancreatic excitation peptide, nifedipine, berberine, beraprost sodium; all for unknown indication and unknown long-acting insulin for diabetes.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30), from cartridge, via a reusable pen (humapen ergo ll), 6 units in the morning, 8 units at night (twice a day), subcutaneously for the treatment of diabetes mellitus beginning in 2009.In 2014, approximately five years after starting human insulin 70/30 therapy, diabetes lesions/complications caused him right ear deafness, which resulted in a sustained disability.Additionally, he had a cataract, ocular fundus hemorrhage and he was not able to walk.The events of ocular fundus hemorrhage and not able to walk were considered serious for medical significance criteria.On an unknown date, he developed insulin antibodies and the doctor discontinued human insulin 70/30 treatment around 2013 or 2014.At the end of (b)(6) 2015, during humapen ergo ll use, he experienced high blood sugar (unknown values) and was hospitalized at the end of (b)(6) 2015.During hospitalization, in (b)(6) 2015, he received unknown long-acting insulin before sleep and had a low blood sugar at night, his blood sugar was 3-4 (units were not provided).Physician helped him to adjust the dose from 14 units to 8 units, but still experienced symptoms of hypoglycemia.Early (b)(6) 2015, he was discharged from the hospital.After discharge he discontinued the unknown long-acting insulin.He was hospitalized every year for unknown reason, no more details were provided.On (b)(6) 2016, he developed high blood sugar and was hospitalized, he was discharged from hospital on (b)(6) 2016, and his doctor restarted human insulin 70/30 therapy.In (b)(6) 2016 humapen ergo ll pen had an unspecified problem ((b)(4)/ lot 0810d01).As of (b)(6) 2016, his postprandial blood glucose (2hrs after meal) was 12.7, no fasting glucose measurement was provided.Information regarding hospitalization details, corrective treatment and outcome of the remaining events was not provided.Human insulin isophane suspension 70%/human insulin 30% therapy was continued.The user of the humapen ergo ll and his or her training status was provided.The humapen ergo ll model was used since 2009 to (b)(6) 2016 approximately seven years.The device was not returned.The reporting consumer did not know if the events were related to the treatment to human insulin isophane suspension 70%/human insulin 30% and humapen ergo ll pen.Update 06apr2016: upon review, the case was opened to add the product complaint number to the narrative, and update the medwatch and european and canadian required device reporting elements for regulatory reporting.Update 12-apr-2016: additional information received from the initial reporter via a psp on 08-apr-2016.Added hospitalization details.Recoded eye disorder to the serious event of ocular fundus hemorrhage and added the non-serious event of cataract.Updated the outcome of the serious event of disability.Updated narrative with new information.Edit 14-apr-2016: pc number was received on 01apr-2016 and processed on 06-apr-2016.No changes were done to the case.Update 02-may-2016: additional information received on 29-apr-2016 from the global product complaint database added the device specific safety summary and manufactured date of the device; added the device length of use; updated the improper use and storage to yes; 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: 5563460
• MDR Text Key: 42416617
• Report Number: 1819470-2016-00090
• 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: 03/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 0810D01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/31/2008
• 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: 67 YR