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

Model Number MS9557

Device Problems Mechanical Problem (1384); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

This is an initial report.A follow-up report will be submitted when the final evaluation is compeleted.

Event Description

(b)(4).This spontaneous case, reported by a consumer who contacted the company to report a product compliant concerns a (b)(6) male patient.Medical history included hepatic cirrhosis.Concomitant medications were not provided.Starting on an unspecified date in 2011 the patient received humulin 30% regular, 70% nph (human insulin (rdna origin) 30% regular, 70% nph) 12 u each morning for treatment of diabetes via a humapen ergo ii device (lot 0805d02/(b)(4)).On (b)(6) 2016 he was unable to inject insulin because the hp ergo ii pen made no clicking sounds when adjusted the dose knob, the injection button could not be pushed down.The consumer was the operator of the device.Training status was unknown.The device had been use for 5 years.There was evidence of improper use as the consumer never changed needles.The device was returned on 25jul2016.Update 30-jun-2016: this case was considered to be non-valid as there was no identifiable event, only a drug dose omission was described.Edit 11-jul-2016.Upon product complaint receipt, the device was recoded.No additional changes made in case.Update 15-jul-2016: follow up information received on 27-jun-2016, included product complaint which was previously processed.No new adverse event information was added to the case.Update 09aug2016.Additional information received 08aug2016 from the product complaint safety database.Changed the case to valid, upgraded to serious, on the device tab changed malfunction to yes, entered type as cirm, changed improper use to yes, entered the european and canadian (eu/ca) device information, entered the device medwatch information, and updated the narrative accordingly.

Manufacturer Narrative

This is a downgrade report, which no longer meets the criteria for expedited reporting.Evaluation summary: a male patient reported his humapen ergo ii device made no clicking sounds when he adjusted the dose knob, the injection button could not be pushed down, and he was unable to inject insulin.Investigation of the returned device (batch 0805d02, manufactured may 2008) found foreign material on external surfaces, cartridge holder printing worn/faded, and the soft touch discolored and loose from the device.A brown, sticky foreign material was present on internal components, preventing the device from rotating and clicking properly when dosing.The clicks could not be heard which was caused by foreign material contamination while in the field (not related to manufacturing).Therefore, the reportable malfunction of clicker issues was not confirmed.The user manual provides the proper instructions for use and care of the device.The patient reported that he "never" changed needles.The call center advised the patient to place a new needle on the device before every injection as instructed in the user manual.The patient also reported using the device for five years.The user manual states the device was designed to be used for up to 3 years after first use.There is evidence of improper use or storage.The foreign material damage to the device occurred while in the field.The patient reused needles and used the device beyond its approved use life.These factors are likely relevant to the complaint that the device made no clicking sounds and injection button could not be pushed down.

Event Description

Lilly case id: (b)(6).This spontaneous case, reported by a consumer who contacted the company to report a product compliant concerns a (b)(6) asian male patient.Medical history included hepatic cirrhosis.Concomitant medications were not provided.Starting on an unspecified date in 2011 the patient received humulin 30% regular, 70% nph (human insulin (rdna origin) 30% regular, 70% nph) 12 u each morning for treatment of diabetes via a humapen ergo ii device (lot 0805d02/pc 3699497).On 20jun2016 he was unable to inject insulin because the hp ergo ii pen made no clicking sounds when adjusted the dose knob, the injection button could not be pushed down.This case was determined to be non valid for no event, other safety information only.The consumer was the operator of the device.Training status was unknown.The device had been use for 5 years.There was evidence of improper use as the consumer never changed needles.The device was returned on 25jul2016.Update 30-jun-2016: this case was considered to be non-valid as there was no identifiable event, only a drug dose omission was described.Edit 11-jul-2016.Upon product complaint receipt, the device was recoded.No additional changes made in case.Update 15-jul-2016: follow up information received on 27-jun-2016, included product complaint which was previously processed.No new adverse event information was added to the case.Update 09aug2016.Additional information received 08aug2016 from the product complaint safety database.Changed the case to valid, upgraded to serious, on the device tab changed malfunction to yes, entered type as cirm, changed improper use to yes, entered the european and (b)(4) (eu/(b)(4)) device information, entered the device medwatch information, and updated the narrative accordingly.Update 23aug2016.Additional information received 22aug2016 from the product complaint safety database.This case was downgraded to non valid non serious for no event; other safety information only.To the device tab added the manufacture date, changed malfunction to no, added the device specific safety summary (dsss), updated the european and (b)(4) (eu/(b)(4)) device information, updated the device medwatch information, and the narrative was updated accordingly.Edit 30aug2016.Upon internal review on the device tab the malfunction was corrected to yes, not company identifiable reportable malfunction (cirm).

• 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: caroline rosewell ; lilly corporate center; indianapolis, IN 46285 ; 3172764376
• MDR Report Key: 5889975
• MDR Text Key: 53789566
• Report Number: 1819470-2016-00211
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K151686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MS9557
• Device Lot Number: 0805D02
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/25/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2008
• 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 Age: 57 YR
• Patient Weight: 63