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

Model Number MS9557

Device Problems Excess Flow or Over-Infusion (1311); Insufficient Flow or Under Infusion (2182)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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 spontaneous case, reported by a consumer, concerned a (b)(6) female patient.Medical history included hypertension.Concomitant medications were not provided.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) (humalog mix 50) cartridge via a reusable pen humapen ergo ii, 24 u in the morning, 4 at noon and 14 in the evening subcutaneously for the treatment of diabetes, beginning around the end of 2014 or the beginning of 2015.On an unreported date at the end of 2014 or the beginning of 2015, the humapen ergo ii was reported that the dose was inaccurate.During the priming process one unit was set and the injection button was depressed.Sometimes on one drop insulin came out and sometimes a lot of insulin came out ((b)(4); lot 1307d02).The humapen ergo ii remained in use.On an unspecified date while on insulin lispro protamine suspension 50%/insulin lispro 50% treatment, her fasting blood sugar was 18 or 19 unspecified units, so she was hospitalized on (b)(6) 2017 to control the blood sugar.Information regarding entrance and discharge dates were not provided.She received metformin by her physician.Outcome of the event was not provided.Insulin lispro protamine suspension 50%/insulin lispro 50% treatment continued.The operator of the humapen and training status was not provided.The general humapen model duration of and suspect humapen duration of use were not provided but started approximately at the end of 2014 or the beginning of 2015.Final action taken with the suspect humapen was not provided.The reporting consumer did not know if the event of blood glucose increased was related to insulin lispro protamine suspension 50%/ insulin lispro 50% drug or device.No opinion of relatedness was provided for the event of inaccurate dose.Update 20-feb-2017: upon review of the source product complaint information from the same reporter from the initial report date of 14feb2017 added a new non serious event of inaccurate dose; added the product complaint information and product complaint number; updated the medwatch and european and canadian required device reporting elements; and updated the narrative.Update 22-feb-2017: additional information was received from the affiliate on 20-feb-2017.The event of blood glucose abnormal was changed to fasting blood glucose increased as received the result of fasting blood glucose level and metformin as treatment.Updated narrative with new information.(b)(4) was received from affiliate on 16-feb-2017 and it was already processed.

Manufacturer Narrative

No further follow up is planned.Evaluation summary: a female patient reported the dose when using her humapen ergo ii device was inaccurate.The patient stated, "during the priming process one unit was set and the injection button was depressed.Sometimes on one drop insulin came out and sometimes a lot of insulin came out." the patient experienced increased blood glucose.The device was not returned to the manufacturer for investigation (batch 1307d02, manufactured july 2013).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 the 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 user manual instructs to prime by dialing to two units, to push injection button, and look for insulin at the needle tip.Therefore, while the patient primed using only one unit, the drop of insulin observed was consistent with the user manual, indicating the pen was properly primed.There is no evidence of improper use or storage.

Event Description

(b)(4).This spontaneous case, reported by a consumer, concerned a (b)(6) female patient.Medical history included hypertension.Concomitant medications were not provided.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) (humalog mix 50) cartridge via a reusable pen humapen ergo ii, 24 u in the morning, 4 at noon and 14 in the evening subcutaneously for the treatment of diabetes, beginning around the end of 2014 or the beginning of 2015.On an unreported date at the end of 2014 or the beginning of 2015, the humapen ergo ii was reported that the dose was inaccurate.During the priming process one unit was set and the injection button was depressed.Sometimes on one drop insulin came out and sometimes a lot of insulin came out (product complaint (b)(4); lot 1307d02).The humapen ergo ii remained in use.On an unspecified date while on insulin lispro protamine suspension 50%/insulin lispro 50% treatment, her fasting blood sugar was 18 or 19 unspecified units, so she was hospitalized on (b)(6) 2017 to control the blood sugar.Information regarding entrance and discharge dates were not provided.She received metformin by her physician.Outcome of the event was not provided.Insulin lispro protamine suspension 50%/insulin lispro 50% treatment continued.The operator of the humapen and training status was not provided.The general humapen model duration of and suspect humapen duration of use were not provided but started approximately at the end of 2014 or the beginning of 2015.The device was not returned to the manufacturer.The reporting consumer did not know if the event of blood glucose increased was related to insulin lispro protamine suspension 50%/ insulin lispro 50% drug or device.No opinion of relatedness was provided for the event of inaccurate dose.Update 20-feb-2017: upon review of the source product complaint information from the same reporter from the initial report date of 14feb2017 added a new non serious event of inaccurate dose; added the product complaint information and product complaint number; updated the medwatch and european and canadian required device reporting elements; and updated the narrative.Update 22-feb-2017: additional information was received from the affiliate on 20-feb-2017.The event of blood glucose abnormal was changed to fasting blood glucose increased as received the result of fasting blood glucose level and metformin as treatment.Updated narrative with new information.(b)(4) was received from affiliate on 16-feb-2017 and it was already processed.Update 08mar2017: additional information received on 08mar2017 from global product complaint database.Entered device specific safety summary (dsss).Added manufactured date of the device.Updated the medwatch fields with device information, the european and canadian (eu/ca) device information, and device return status to device was not returned to 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: 6376220
• MDR Text Key: 69014996
• Report Number: 1819470-2017-00040
• 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: 03/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 1307D02
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2013
• 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: HUMALOG
• Patient Outcome(s): Hospitalization
• Patient Age: 53 YR
• Patient Weight: 68