MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN, UNKNOWN DEVICE; NSC FOR TREATMENT PURPOSES

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Hypoglycemia (1912); Numbness (2415)

Event Date 01/31/2015

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 who contacted the company to report adverse events and product complain (pc), with additional information from the initial reporter, concerned a female patient of unknown age and origin.Medical history included numbness of hand and eye problems.Concomitant medications included mecobalamin and unknown drug reported as yikai (pancreatic kininogenase enteric coated tablet), both for unknown indication.Also she took an unspecified medication for eyes.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) (humalogmix50) via cartridge using reusable pen (humapen ergo ii and unspecified pen humapen), for the treatment of diabetes mellitus, subcutaneously, beginning in 2015; initial dose and frequency were not reported.On unknown date she experienced high blood glucose and hypoglycemia that led to hospitalization twice (pc: unknown lot number:1201d03; pc: unknown lot number:unknown).In 2016 she was hospitalized for unknown reason.On (b)(6) 2017 she had night hypoglycemia.She did not receive corrective treatment, she only ate bread and then she was recovering.No lab test were reported for the glucose events.On unknown date she decreased her dose to 18 units in the morning and 18 units in the evening.Information regarding further corrective treatment was not reported.Insulin lispro protamine suspension 50%/insulin lispro 50% treatment was continued.Information regarding further hospitalization details were not provided.Follow up was not possible since the reporter refused to be contacted and no information regarding the treating physician was provided.Information regarding the operator of the device and his/her training status was not provided.The device model duration of use and the suspect device duration of use were no reported but the use started in 2015.The action taken was not reported; however its return was not expected.The reporting consumer did not know if the events were related to insulin lispro protamine suspension 50%/insulin lispro 50% treatment and did not provide an opinion regarding the devices.Update 13-jul-2017: additional information received from the initial reporter on 11-jul-2017.Updated the corrective treatment from unknown to no and outcome from not recovered as conflictive information to recovering for the non-serious hypoglycemia; and narrative with new information.Update 17jul2017: updated medwatch fields for expedited device reporting.Update 17-jul-2017: a correction was received from the affiliate regarding the initial information of 04-jul-2017.Deleted irbesartan as concomitant drug and added unknown drug reported as yikai.Updated onset date for the hospitalization without cause provided in narrative.Narrative and fields were updated accordingly.

• Brand Name: HUMAPEN, UNKNOWN DEVICE
• Type of Device: NSC 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: 6761249
• MDR Text Key: 81633200
• Report Number: 1819470-2017-00125
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 08/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/04/2017
• Was Device Evaluated by Manufacturer?: No
• 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 50% LISPRO, 50%NPL; MECOBALAMINE
• Patient Outcome(s): Hospitalization