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

Model Number MS9557

Device Problem Mechanical Problem (1384)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Manufacturer Narrative

Narrative field: new, updated and corrected information is referenced within the update statements.Please refer to update statement dated 08apr2019.No further follow-up is planned.Evaluation summary: a male patient reported that the dose knob of his humapen ergo ii device could still be rotated as some of the insulin remained in the cartridge and the injection button could not be pushed down.The patient experienced increased blood glucose.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

Lilly case id: (b)(4).This report is associated with product compliant: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) male patient of unknown origin.Medical history (comorbidity, allergy history), drug adverse reaction history, family drug adverse reaction and concomitant medications were not provided.The patient received insulin lispro protamine suspension 50%/ insulin lispro 50% (rdna origin) injections (humalog mix50) from cartridge via a reusable humapen ergo ii pen, subcutaneously, for treatment of unknown indication, beginning on an unknown date.Dose and frequency was not provided.On an unknown date, after starting insulin lispro protamine suspension 50%/ insulin lispro 50%, he was diagnosed with high blood glucose (no values or units provided).After the cartridge of insulin lispro protamine suspension 50%/ insulin lispro 50% was used up, the dose knob of a humapen ergo ii could still be rotated as some of the insulin remained in the cartridge and the injection button could not be pushed down ((b)(4)/lot no.Unknown).He himself tested the blood glucose and was hospitalized due to high blood glucose.As a corrective treatment he received unspecified insulin injection in the hospital.As of (b)(6) 2019, he was discharged from the hospital.Outcome of the event was unknown.Insulin lispro protamine suspension 50%/ insulin lispro 50% therapy was discontinued on an unknown date due to unknown reason and it was unknown if the therapy was restarted.The patient was the operator of humapen ergo ii and his training status was unknown.The general device duration and the suspect device duration of use was not provided.The suspect product was not returned to the manufacturer.The reporting consumer did not provide the opinion of relatedness between the event and insulin lispro protamine suspension 50%/ insulin lispro 50% or the humapen ergo ii.Update 25-feb-2019: this case was determined to be non-valid as there was no identifiable valid adverse event and suspect product.Patient was hospitalized for unknown reason.Update 28-feb-2019: information received from affiliate on 26-feb-2019.No new medically significant information was received or added to the case.Update 25-mar-2019: this case was initially determined to be non-valid (no valid event and product identifiable).Additional information was received from the initial reporter via psp on (b)(6) 2019, which contained a valid event and product.The priority of the case was upgraded.Added blood glucose lab data and removed laboratory date.Added treatment drug.Added serious event of blood glucose increased and removed serious event of hospitalization.Recoded the suspect drug from lispro unknown formulation to insulin lispro protamine suspension 50%/ insulin lispro 50% cartridge.Updated concomitant device to suspect device and processed pc accordingly.Updated causality statement and narrative with new information.Edit 28mar2018: updated medwatch and european and (b)(4) (eu/(b)(4)) fields for expedited device reporting.No new information added.Update 08apr2019: additional information received on 05apr2019 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch/european and (b)(4) (eu/(b)(4)) device information and device return status to not returned to manufacturer for (b)(4) associated with unknown lot of a humapen ergo ii device.Corresponding fields and narrative updated 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: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 8500846
• MDR Text Key: 141585254
• Report Number: 1819470-2019-00063
• 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,consum
• Type of Report: Initial
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9557
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2019
• 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
• Patient Age: 33 YR