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

Model Number UNKNOWN

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

Describe event or problem: new updated and corrected information is referenced within the update statements.Please refer to statement dated 22mar2019.No further follow up is planned.This report is associated with 1819470-2019-00060 since there is more than one device implicated.Evaluation summary: a male patient reported that his humapen (unspecified device) was not working.He experienced abnormal blood glucose.The device was not returned to the manufacturer for investigation (batch unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.All humapen 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.

Event Description

Lilly case id: (b)(4).This report is associated with product compliant: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and product complaints (pc), concerned a male patient of unknown age and origin.Medical history, previous drug adverse reaction, family drug reaction and concomitant medications were not provided.The patient received human insulin (rdna origin) injections (humulin 100u/ml, specific type unknown) from cartridge via unknown humapen, for the treatment of diabetes mellitus, beginning on an unknown date.Dosage regimen and start date was not provided.On an unknown date, after human insulin, his blood sugar was control not well (no values or units provided) and then he was hospitalized for the treatment of the event.The doctor advised him to use aspart (as reported) as a corrective treatment but his blood sugar was still not controlled (no values or units provided).At the same time, he experienced diabetes complications that caused eye diseases.Additionally, he had two humapen that did not work (pc number (b)(4)/ lot number unknown) and the second humapen was skid (pc number (b)(4)/ lot number unknown).On an unknown date, human insulin therapy was discontinued due to unknown reason.On an unknown date he started using insulin lispro protamine suspension 50%/ insulin lispro 50% (rdna origin) injections (humalog mix50) under the doctor recommendation.Further information regarding corrective treatment, hospitalization details and events outcome was not provided.Human insulin therapy status was unknown.Follow up would not be possible as the reporter refused to accept follow-up via the phone and physician contact information was not provided.The operator of the humapens and his/her training status was not provided.The humapens model duration of use and the reported humapens duration of use was not provided.The humapens were discarded; therefore were not returned to the manufacturer.The reporting consumer did not know if the events were related to human insulin therapy and did not provide the opinion of relatedness between the events and the humapens.Update 22mar2019: additional information received on 20mar2019 from the global product complaint database.Entered the device specific safety summary (dsss).Updated the medwatch and european and (b)(4) (eu/(b)(4)) device fields for the suspect devices associated with pc (b)(4).Corresponding fields and narrative updated accordingly.

• Brand Name: HUMAPEN, UNKNOWN DEVICE
• 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: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 8496766
• MDR Text Key: 141446764
• Report Number: 1819470-2019-00061
• 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: 04/09/2019

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/12/2019
• Initial Date FDA Received: 04/09/2019
• 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