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

Model Number UNKNOWN

Device Problem No Flow (2991)

Patient Problem Complaint, Ill-Defined (2331)

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.This report is associated with 1819470-2018-00113 and 1819470-2018-00115, since there is more than one device implicated.

Event Description

(b)(6) 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 an adverse event and product complaint (pc), concerned a female patient of an unspecified age and origin.Medical history and concomitant medications were not provided.Drug adverse reaction history and family drug adverse reaction were unknown.The patient received human insulin (rdna origin) injections (humulin 100 u/ml cartridge) via reusable device (humapen unknown), dosage and frequency were not provided subcutaneously for the treatment of diabetes mellitus, beginning from 2016.On an unknown date, after starting human insulin, she had three humapens that she got replaced in 2016, 2017 and (b)(6) 2018.On an unknown date, the injection buttons of all the three replaced humapens could be pressed down, the screw rod could be pushed out but the liquid could not be pressed out, which resulted in her to be hospitalized to control disease (pc 4402716/ lot number unknown, pc 4402718/ lot number, pc 4402719/ lot number unknown).Information regarding hospitalisation details, outcome of the event and corrective treatment was not provided.Human insulin therapy was discontinued on an unknown date.The user of the humapen and his or her training status were not provided.The humapens model duration of use was not provided but it was started between 2014 to 2015.The three suspect humapens duration of use was not reported but it was started in 2016, 2017 and (b)(6) 2018 respectively.The use of the three suspect humapens was discontinued on an unknown date.The action taken with the suspect humapens and their return status were not provided.The reporting consumer did not know about relatedness assessments between events and human insulin drug and did not provide a relatedness assessment for the event with humapens.Update 04-jul-2018: additional information was received from the regional complaint personnel regarding pc number on 02-jul-2018.Updated the coding of the suspect and concomitant device from humapen unknown body type to humapen ergo ii.Updated narrative with new information.Edit 09-jul-2018: upon review of initial information the suspect and concomitant devices were re-coded from humapen ergo ii to humapen unknown.No new adverse event information was added to the case.Update 11jul2018: updated medwatch fields for expedited device reporting.No new information added.

Manufacturer Narrative

B.5.Narrative field; new updated and corrected information is referenced within the update statements in b.5.Please refer to statement dated 27jul2018 in the b.5.Field.No further follow up is planned.This report is associated with 1819470-2018-00113 and 1819470-2018-00115, since there is more than one device implicated.Evaluation summary: a female patient reported the injection button of her humapen (unspecified device) could be pushed down and the injection screw could be pushed out, but no insulin flowed out.The patient experienced inadequate control of diabetes mellitus.The device was not returned 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 with high probability.There is no evidence of improper use.

Event Description

Lilly case id: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report an adverse event and product complaints (pc), with additional information from initial reporter in response to a questionnaire, concerned a female patient of an unspecified age and origin.Medical history and concomitant medications were not provided.The patient would be hospitalized one or two times every year to regulate blood sugar.Drug adverse reaction history and family drug adverse reaction were unknown.The patient received human insulin (rdna origin) injections (humulin 100 u/ml cartridge) via reusable pen (humapen unknown) subcutaneously for the treatment of diabetes mellitus, beginning in 2016.Dosage regimen was not provided.On an unknown date, after starting human insulin, she had three humapens that were obtained from 2014 to 2016 and that got replaced respectively in 2016, 2017 and jun-2018.On an unknown date, the injection buttons of all three replaced humapens could be pressed down, the screw rod could be pushed out but the liquid could not be pressed out, and as a result she was hospitalized to control disease due to high blood sugar level (values not provided) ((b)(4).Lot number unknown; (b)(4).Lot number unknown; (b)(4).Lot number unknown).Information regarding hospitalization dates, diagnostic tests, outcome of the event and corrective treatments was not provided.Human insulin therapy was discontinued on an unknown date.The patient was the operator of the humapen and she was an untrained user.The humapens model duration of use was not provided.The three suspect devices duration of use were not reported.The three suspect humapen unknowns were discontinued on an unknown date were not returned to the manufacturer.The reporting consumer was not sure if the event was related to human insulin treatment and did not provide an assessment of relatedness between the event and the humapens.Update 04-jul-2018: additional information was received from the regional complaint personnel regarding pc number on 02-jul-2018.Updated the coding of the suspect and concomitant device from humapen unknown body type to humapen ergo ii.Updated narrative with new information.Edit 09-jul-2018: upon review of initial information the suspect and concomitant devices were re-coded from humapen ergo ii to humapen unknown.No new adverse event information was added to the case.Update 11jul2018: updated medwatch fields for expedited device reporting.No new information added.Update 26-jul-2018: additional information received on 25-jul-2018 from initial reporter in response to a questionnaire.Recoded event from diabetes mellitus inadequate control to blood glucose increased.Added hospitalization for blood glucose regulation as medical history and a blood glucose lab test.For all suspect humapens, updated operator of device from unknown to lay user/patient and trained user from unknown to no.Upon review recoded suspect drug formulation from unknown to cartridge.Updated narrative and corresponding fields accordingly.Update 27jul2018: additional information received on 25jul2018 and 27jul2018 from the global product complaint database were processed together.Entered the device specific safety summary (dsss) and updated the medwatch and european and canadian (eu/ca) device fields for the suspect devices associated with (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
• MDR Report Key: 7719427
• MDR Text Key: 115010436
• Report Number: 1819470-2018-00114
• 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,Followup
• Report Date: 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2018
• 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
• Date Manufacturer Received: 07/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization