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 Infarction, Cerebral (1771)

Event Date 01/31/2014

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 health care professional (hcp) via a patient support program (psp), concerned a (b)(6) female patient of unknown origin.Medical history was not reported.Concomitant medication included unspecified (b)(6) medicine for invigorating blood circulation and eliminating stasis.The patient received human insulin isophane suspension 70%/ human insulin 30% (rdna origin) (humulin 70/30; 100 u/ml) via reusable pen (humapen ergo ii) 10 at morning, 14 at noon at 24 at night (units were not provided), subcutaneously for the treatment of diabetes mellitus, beginning in 2014.Sometime in 2014, she experienced a cerebral infarction; as a result, her speaking was not very clear.Cerebral infarction was considered serious due to its medical significance.Since 2014, she was hospitalized two times every year to adjust blood glucose.It was reported that hospitalizations lasted half month every time.Information regarding hospitalization dates and laboratory test while hospitalized were not provided.Information regarding corrective treatments and outcome of the events was not provided.On an unreported date, a product complaint occurred for the humapen ergo ii ((b)(4)/ lot 1202d02).Human insulin 30/70 treatment was continued.The user of the humapen ergo ii and his/her training status was not provided.The humapen ergo ii model and suspect humapen ergo ii duration of use was of approximately two years.The device use was discontinued on (b)(6) 2016 the reporting hcp did not know if the events were related to human insulin 30/70 or humapen ergo ii update 18-nov-2016: upon review, this case was opened to update the medwatch and european and canadian required device reporting elements for regulatory reporting; the product complaint information and product complaint number were added; and the narrative was updated.Update 24-nov-2016: additional information received from the initial reporter on 23-nov-2016 via psp.Lack of contact information of hcp, follow up could be attempted.A second attempt for follow up would be pursued.No further changes were made to this case.Update 06-dec-2016: additional information received on 02-dec-2016 from the affiliate.No follow up was performed.No new medically significant information was provided.

Manufacturer Narrative

No further follow up is planned.Evaluation summary: a female patient reported the injection screw of her humapen ergo ii device would not move out.The patient experienced abnormal blood glucose levels.The device was not returned to the manufacturer for investigation (batch number 1202d02, manufactured february 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 injection screw/ratchet not moving or dose accuracy complaints.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

Lilly case id: (b)(6).This solicited case, reported by a health care professional (hcp) via a patient support program (psp), concerned a (b)(6) female patient of unknown origin.Medical history was not reported.Concomitant medication included unspecified chinese medicine for invigorating blood circulation and eliminating stasis.The patient received human insulin isophane suspension 70%/ human insulin 30% (rdna origin) (humulin 70/30; 100 u/ml) via reusable pen (humapen ergo ii) 10 at morning, 14 at noon at 24 at night (units were not provided), subcutaneously for the treatment of diabetes mellitus, beginning in 2014.Sometime in 2014, she experienced a cerebral infarction; as a result, her speaking was not very clear.Cerebral infarction was considered serious due to its medical significance.Since 2014, she was hospitalized two times every year to adjust blood glucose.It was reported that hospitalizations lasted half month every time.Information regarding hospitalization dates and laboratory test while hospitalized were not provided.Information regarding corrective treatments and outcome of the events was not provided.On an unreported date, a product complaint occurred for the humapen ergo ii (product complaint 3827027/ lot 1202d02).Human insulin 30/70 treatment was continued.The user of the humapen ergo ii and his/her training status was not provided.The humapen ergo ii model and suspect humapen ergo ii duration of use was of approximately two years.The device use was discontinued on (b)(6) 2016.The device was not returned.The reporting hcp did not know if the events were related to human insulin 30/70 or humapen ergo ii.Update 18-nov-2016: upon review, this case was opened to update the medwatch and european and canadian required device reporting elements for regulatory reporting; the product complaint information and product complaint number were added; and the narrative was updated.Update 24-nov-2016: additional information received from the initial reporter on 23-nov-2016 via psp.Lack of contact information of hcp, follow up could be attempted.A second attempt for follow up would be pursued.No further changes were made to this case.Update 06-dec-2016: additional information received on 02-dec-2016 from the affiliate.No follow up was performed.No new medically significant information was provided.Update 08-dec-2016: additional information received on 08-dec-2016 from the global product complaint database added the device specific safety summary and manufactured date of the device; 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: 6147710
• MDR Text Key: 61532664
• Report Number: 1819470-2016-00314
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/11/2016

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
• Device Lot Number: 1202D02
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/11/2016
• Initial Date FDA Received: 12/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2012
• 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: INSULIN HUMAN
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR
• Patient Weight: 70