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

Model Number MS9557

Device Problem Failure to Advance (2524)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/30/2016

Event Type  Injury  

Manufacturer Narrative

New updated and corrected information is referenced within the update statement.No further follow-up is planned.Evaluation summary: a male patient reported that the screw on his humapen ergo ii device did not move.The device was not returned to the manufacturer for investigation (batch number unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.All humapen ergo ii devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality with high probability.There is no evidence of improper use or storage.

Event Description

(b)(4).This spontaneous case, reported by a consumer who contacted the company to report an adverse event and a product complaint (pc), with additional information from the initial reporter, concerned a (b)(6) male patient.Medical history included his eyes were not good (conflicting information, also reported as his eyes were ok).Concomitant medications included acarbose, metformin and metformin hydrochloride, all for unknown indication of use.The patient received insulin lispro protamine suspension 75%/ insulin lispro 25% (rdna origin) (humalog mix25) cartridge, via reusable pen (humapen ergo ii), 24 (no units provided) twice daily (in the morning and at night), subcutaneously, for the treatment of diabetes.Start date was not provided.On an unspecified date, he stopped insulin lispro protamine suspension 75%/ insulin lispro 25% treatment due to unknown reason.In (b)(6) 2016, he was hospitalized because his blood glucose was high (specific values were not provided).Reportedly, the screw of the humapen ergo ii did not move ((b)(4)/lot number: unknown).He restarted insulin lispro protamine suspension 75%/ insulin lispro 25% followed by his physician prescription and shortly after that, he experienced an eyeground hemorrhage (as reported).Color photo of fundus, ocular fluorescein angiography and another unspecified test were performed, and finally vascular terminal bleeding was diagnosed, but the specific reason for eye hemorrhage remained unknown.By (b)(6) 2017, it was stated that it was a bleeding of small vessels in eyes, not big blood vessels.He did not know the specific name of small blood vessels.Corrective treatment and outcome of the events were unknown.Insulin lispro protamine suspension 75%/ insulin lispro 25% treatment was continued.The user of the humapen ergo ii and his/ her training status was not provided.The humapen ergo ii model duration of use and the suspect humapen ergo ii duration of use were not reported.The action taken with the suspect humapen ergo ii was not provided and its return was not expected.The reporting consumer did not know if the events were related to insulin lispro protamine suspension 75%/ insulin lispro 25% treatment and did not provide an assessment of relatedness between the events and the suspect humapen ergo ii.Edit 10-oct-2017: upon review of initial information received on 20-sep-2017, and after receiving pc numbers, a suspect humapen ergo ii and a concomitant humapen ergo ii were added, therefore the priority of the case was changed to p1.Pcs were processed accordingly.Update 10-oct-2017: additional information received from the initial reporter on 09-oct-2017.Added: laboratory tests of ocular fluorescein angiography, and color photo of fundus.Narrative was updated with new information regarding medical history.Update 13-oct-2017: additional information was received in response to a medical questionnaire by the initial reporter on 12-oct-2017.Updated description as reported of eye hemorrhage events and narrative details.Update 16oct2017.Additional information received 15oct2017 from the product complaint safety database.To the device tab (device 1) entered the device specific safety summary (dsss), updated the medwatch and the european and canadian (eu/ca) device fields, and updated the narrative 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: 6961398
• MDR Text Key: 89740626
• Report Number: 1819470-2017-00197
• 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
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MS9557
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 53 YR
• Patient Weight: 90