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

Model Number MS9557

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 06/12/2016

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), concerns a (b)(6) male (b)(6) patient.Medical history included being hospitalized in 2010 due to an unknown reason.Concomitant medications were not reported.The patient received insulin lispro (rdna origin) injections (humalog u100) cartridges subcutaneously via humapen ergo ii, 8 unspecified units in the morning and 8 in the evening, for the treatment of diabetes mellitus beginning during hospitalization in 2010.On (b)(6) 2016, six years after stating insulin lispro, his blood glucose could not be controlled (no values, units or reference ranges were provided).Because of the uncontrolled blood glucose he was admitted to the hospital (it was unclear if he was admitted on (b)(6) 2016).He had his insulin lispro dose adjusted according to his blood glucose by his physicians instructions to 14 unspecified units in the morning and 14 in the evening.In addition, the injection button on his humapen ergo ii slipped down when pressing down, he had the pen replaced while on the hospital on (b)(6) 2016 (pc unknown/lot number 1010d02).Information regarding corrective treatment and outcome of the event was not provided.Insulin lispro treatment was continued.The operator of the humapen ergo ii and his or her training status was unknown.The humapen ergo ii model duration of use was of approximately six years.The humapen ergo ii was no longer in use, the use stopped on (b)(6) 2016; if returned an evaluation would be performed to determine if a malfunction had occurred.The reporting consumer did not know if the event was related to insulin lispro treatment of humapen ergo ii or not.Edit 17jun2016.Case was opened to enter the european/canadian device fields and medwatch device fields for device mailing.No new information.

Manufacturer Narrative

Evaluation summary down.The patient experienced abnormal blood glucose levels.The device was not returned for investigation (batch (b)(4), manufactured october 2010).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 device not working or dose accuracy.All humapen ergo ii devices are assessed for injection screw travel at the end of the manufacturing process, which ensures dose accuracy with high probability.The patient stated he used his ergo ii device for approximately six years (approximately 5.5 years based on manufacture date).The user manual states the humapen ergo ii device has been designed to be used for up to 3 years, after first use.There is evidence of improper use.The patient used the device beyond its approved use life.This may be relevant to the patient's complaint, but it is unknown if this is relevant to the abnormal blood glucose levels.

Event Description

(b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerns a (b)(6) male (b)(6) patient.Medical history included being hospitalized in 2010 due to an unknown reason.Concomitant medications were not reported.The patient received insulin lispro (rdna origin) injections (humalog u100) cartridges subcutaneously via humapen ergo ii, 8 unspecified units in the morning and 8 in the evening, for the treatment of diabetes mellitus beginning during hospitalization in 2010.On (b)(6) 2016, six years after stating insulin lispro, his blood glucose could not be controlled (no values, units or reference ranges were provided).Because of the uncontrolled blood glucose he was admitted to the hospital (it was unclear if he was admitted on (b)(6) 2016).He had his insulin lispro dose adjusted according to his blood glucose by his physicians instructions to 14 unspecified units in the morning and 14 in the evening.In addition, the injection button on his humapen ergo ii slipped down when pressing down, he had the pen replaced while on the hospital on (b)(6) 2016 (pc unknown/lot number 1010d02).Information regarding corrective treatment and outcome of the event was not provided.Insulin lispro treatment was continued.The operator of the humapen ergo ii and his or her training status was unknown.The humapen ergo ii model duration of use was of approximately six years (improper use/.Exceeded shelf life).The humapen ergo ii was no longer in use, the use stopped on (b)(6) 2016.The status of the device was unknown.The reporting consumer did not know if the event was related to insulin lispro treatment of humapen ergo ii or not.Edit 17jun2016.Case was opened to enter the european/canadian device fields and medwatch device fields for device mailing.No new information.Update 29jun2016.Additional information received 28jun2016 from the product complaint safety database.To the device tab added the device specific safety summary (dsss), updated the european and canadian (eu/ca) device information, updated the device medwatch information, added the manufacture date, changed improper use to yes, and the narrative was 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: 5754627
• MDR Text Key: 48306917
• Report Number: 1819470-2016-00150
• 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: 06/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2016
• 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?: No
• Date Manufacturer Received: 06/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 67 YR
• Patient Weight: 70