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

Model Number MS9557

Device Problems Improper or Incorrect Procedure or Method (2017); Defective Component (2292)

Patient Problems Hyperglycemia (1905); Dizziness (2194)

Event Type  Injury  

Manufacturer Narrative

Narrative field: new, updated and corrected information is referenced within the update statements.Please refer to update statement dated 13jul2018.No further follow-up is planned.Evaluation summary : a patient reported the injection screw of their humapen ergo ii device could not touch the cartridge plunger and the patient could inject insulin.The patient experienced increased blood glucose.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 ergo ii devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality with high probability.The patient reported not priming before injection.The core user manual instructs the patient to prime the device using 2 units before every injection until insulin is seen at the needle tip.There is evidence of improper use.The patient did not prime the device before each injection.This may be relevant to the event of increased blood glucose.

Event Description

(b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and product complaint (pc), concerned a patient of an unknown age, gender and origin.Medical history was not reported.Concomitant medications included unspecified insulin used for unknown indication.The patient received insulin lispro (rdna origin) (humalog 100 u/1ml) from a reusable humapen ergo ii device 6 units in morning, 8 units in noon and 10 units at night, subcutaneously for the treatment of diabetes mellitus beginning on an unknown date in (b)(6) 2015.Patient was also using insulin human (rdna) (humulin) specific formulation was unknown, from a reusable humapen ergo ii device, for the treatment of diabetes mellitus beginning on an unknown date in (b)(6) 2016.Dose, frequency, and route of administration of insulin human therapy were not reported.On an unknown date, after starting of insulin lispro and insulin human therapy, the injection screw of their humapen ergo ii device could not touch the cartridge plunger ((b)(4)/lot unknown).Due to the failure of the humapen ergo ii device, the patient did not inject insulin into the body and experienced the symptoms such as blood sugar becoming high (values and reference range not provided) and dizziness appeared.The patient went to the hospital for treatment.In addition, the patient reported not priming before injection.Information regarding corrective treatment and outcome of the events was not reported.Insulin lispro and insulin human therapy was continued.The operator of the humapen ergo ii device and its training status was unknown.The general device duration of use was not reported, beginning on an unknown date and the suspect device duration of use was not provided.It was unknown if the use of the suspect device was continued.The suspect device with (b)(4) was not returned to the manufacturer.The reporting consumer was not sure for relatedness of the events with insulin lispro protamine suspension and human insulin isophane suspension and did not provide relatedness with device.Update 10jul2018: updated medwatch fields for expedited device reporting.No new information added.Update 13jul2018: additional information received on 12jul2018 and 13jul2018 from the global product complaint database both were processed together.Recoded the suspect humapen (unknown body type) to a humapen ergo ii.Entered an updated device specific safety summary (dsss).Updated the medwatch/european and (b)(6) device information, improper use and storage from no to yes, and device return status to not returned to manufacturer for (b)(4) associated with an unknown lot of a humapen ergo ii.Corresponding fields and narrative updated accordingly.Edit 23jul2018: updated medwatch and european and (b)(6) fields for expedited device reporting.No new information added.

• 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: 7735525
• MDR Text Key: 115592017
• Report Number: 1819470-2018-00120
• 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: 07/31/2018

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: Other
• Device Model Number: MS9557
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/04/2018
• Initial Date FDA Received: 07/31/2018
• 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