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

Model Number MS9557

Device Problems Failure to Prime (1492); Device Inoperable (1663)

Patient Problems Hypersensitivity/Allergic reaction (1907); Urinary Frequency (2275)

Event Date 11/01/2016

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) caucasian male patient.Medical history included an accident in 2011 and had a joint fracture before insulin usage; he could not move his joint well till (b)(6) 2017 and had some problems in his leg nerves.Concomitant medications included metformin hydrochloride for diabetes mellitus, benfotiamine with cyanocobalamin/ pyridoxine hydrochloride as a vitamin supplementation, atorvastatin calcium for an unknown indication, acetylsalicylic acid for blood coagulation and amlodipine besilate for hypertension.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humulin 70/30), from a cartridge, via humapen ergo ii, two times a day (40 iu before breakfast and 25 iu before dinner), subcutaneously for the treatment of diabetes mellitus, beginning in (b)(6) 2014.Sometime approximately in (b)(6) 2016, while on treatment with human insulin isophane suspension 70%/human insulin 30%, he suffered from hypersensitivity.He had been taking loratadine for hypersensitivity.On (b)(6) 2016 his fasting blood glucose level measurement was (228 mg/dl), two hours post prandial blood glucose level was (261 mg/dl) and glycosylated hemoglobin (hba1c) was 11.1 (units were not provided), so his health care professional (hcp) added insulin lispro.The event of increased blood glucose was considered serious due to other medical significance.On an unspecified date, he felt his blood glucose level was high (units and values were not provided) as he had excessive urination especially during night so he stop administering both insulins.Since an unspecified date his pen was not working as the pen screw did not work well and was not injecting insulin, he tried priming and the pen was not working (product complaint (b)(4), lot number 1206d0l).This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) caucasian male patient.The operator of the humapen ergo ii was patient and his training status was not provided.The humapen ergo ii model duration of use was not provided.The suspect humapen ergo ii duration of use was not reported.The action taken with the humapen savvio was not provided and its return was not expected.The reporting consumer did not provide a relatedness assessment between the events and human insulin isophane suspension 70%/human insulin 30% treatment or humapen ergo ii pen.Update 03mar2017: upon review, the case was opened to update the medwatch fields for regulatory reporting.

Manufacturer Narrative

New updated and corrected information is referenced within the update statements in describe event or problem.No further follow up is planned.Evaluation summary a male patient reported his humapen ergo ii device was not working as the pen screw did not work well and was not injecting insulin.The patient experienced increased blood glucose.The device was not returned to the manufacturer for investigation (batch number 1206d01, manufactured june 2012).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 findings with respect to device not working.All humapen ergo ii devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy with high probability.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 included an accident in 2011 and had a joint fracture before insulin usage; he could not move his joint well till (b)(6) 2017 and had some problems in his leg nerves.Concomitant medications included metformin hydrochloride for diabetes mellitus, benfotiamine with cyanocobalamin/ pyridoxine hydrochloride as a vitamin supplementation, atorvastatin calcium for an unknown indication, acetylsalicylic acid for blood coagulation and amlodipine besilate for hypertension.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humulin 70/30), from a cartridge, via humapen ergo ii, two times a day (40 iu before breakfast and 25 iu before dinner), subcutaneously for the treatment of diabetes mellitus, beginning in (b)(6) 2014.Sometime approximately in (b)(6) 2016, while on treatment with human insulin isophane suspension 70%/human insulin 30%, he suffered from hypersensitivity.He had been taking loratadine for hypersensitivity.On (b)(6) 2016 his fasting blood glucose level measurement was (228 mg/dl), two hours post prandial blood glucose level was (261 mg/dl) and glycosylated hemoglobin (hba1c) was 11.1 (units were not provided), so his health care professional (hcp) added insulin lispro.The event of increased blood glucose was considered serious due to other medical significance.On an unspecified date, he felt his blood glucose level was high (units and values were not provided) as he had excessive urination especially during night so he stop administering both insulins.Since an unspecified date his pen was not working as the pen screw did not work well and was not injecting insulin, he tried priming and the pen was not working ((b)(4), lot number 1206d01).This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) male patient.The operator of the humapen ergo ii was patient and his training status was not provided.The humapen ergo ii model duration of use was not provided.The suspect humapen ergo ii duration of use was not reported.The action taken with the humapen savvio was not provided.The device was not returned to the manufacturer.The reporting consumer did not provide a relatedness assessment between the events and human insulin isophane suspension 70%/human insulin 30% treatment or humapen ergo ii pen.Update 03mar2017: upon review, the case was opened to update the medwatch fields for regulatory reporting.Update 20mar2017: additional information received on 20mar2017 from global product complaint database.Changed the lot number from 1206d0l to 1206d01 for (b)(4) relating to the humapen ergo ii.Corresponding fields and narrative updated accordingly.Update 27mar2017: additional information received on 27mar2017 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information and the european and canadian (eu/ca) device information.Added date of manufacturer.Corresponding fields and narrative 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: 6414538
• MDR Text Key: 70297673
• Report Number: 1819470-2017-00056
• 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: 04/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MS9557
• Device Lot Number: 1206D01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2012
• 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: ASPOCID; ATOR; GLUCOPHAGE; INSULIN HUMAN; MILGA; NORVASC
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 140