MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN LUXURA BURGUNDY; FOR TREATMENT PURPOSES

Model Number MS9662

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Type  Injury  

Manufacturer Narrative

Product complaint: pending.If device is returned, evaluation will be performed to determine if a malfunction has occurred.A follow-up report will be submitted when the final evaluation is completed.

Event Description

(b)(4).This report is associated with product complaint: pending.This spontaneous case, reported by a consumer, who contacted the company to report adverse events and a product complaint (pc), concerns a chinese female patient of unknown age.Medical history included hypertension.Concomitant medication was not reported.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) (humalog mix 50), via a reusable pen (humapen unknown type), 12 units each morning, 15 units each evening, subcutaneously for the treatment of diabetes mellitus starting in 2013.During the therapy with insulin lispro protamine suspension 50%/insulin lispro 50%, her blood glucose was not good (values not reported), hypertension (unknown if preexisting condition worsened) and diabetes complications after taking medication, and because of these events she was hospitalized many times.She received unspecific treatment at hospital.Further details regarding hospitalization, including admission and discharge dates were not reported.In (b)(6) 2016, she did not administer insulin lispro protamine suspension 50%/insulin lispro 50% due to humapen injection button could not be pressed down.Information regarding outcome of the events was not reported.Insulin lispro protamine suspension 50%/insulin lispro 50% treatment continued.The operator of the humapen unknown type was the patient and her training status was not reported.The general and suspect device was started in 2013 and stopped in (b)(6) 2016.If device was returned, an evaluation would be performed to determine if a malfunction had occurred.The reporting consumer did not know if the events were related to insulin lispro protamine suspension 50%/insulin lispro 50% or humapen device.Edit (b)(6) 2016.Case was opened to enter medwatch and update (b)(4) device fields for device mailing.No new information.

Manufacturer Narrative

Narrative field - new, updated and corrected information is referenced within the update statements.Please refer to update statement dated (b)(6) 2016 in the field.No further follow up is planned.Evaluation summary: a female patient reported that the injection button on her humapen luxura device could not be pressed down.The patient experienced abnormal blood glucose.The investigation of the returned device (batch (b)(4), manufactured december 2011) found the device met dose accuracy specifications, but did not meet glide (injection) force specifications.Malfunction confirmed.Examination of the device found an oily foreign material on multiple internal parts of the device.The foreign material observed caused mechanical difficulties with the device, inhibiting proper movement of the injection screw when dosing.There are several inspection points throughout the manufacturing process which would have rejected the components if observed to have been contaminated by the foreign material.Therefore, the observed foreign material was introduced while in the field and not during the manufacturing of the device.The user manual states, "do not use alcohol, hydrogen peroxide, bleach, cover in liquid or apply lubrication such as oil, as this could damage the pen." there is evidence of improper use.The device was contaminated with foreign material while in the field (not related to the manufacturing process).This may be relevant to the complaint of abnormal blood glucose.

Event Description

(b)(4).This spontaneous case, reported by a consumer, who contacted the company to report adverse events and a product complaint (pc), concerns a (b)(6) female patient of unknown age.Medical history included hypertension.Concomitant medication was not reported.The patient received insulin lispro protamine suspension (b)(4) insulin lispro (b)(4) (rdna origin) (humalog mix 50), via a reusable pen (humapen luxura burgundy), (b)(4) units each morning, (b)(4) units each evening, subcutaneously for the treatment of diabetes mellitus starting in 2013.During the therapy with insulin lispro protamine suspension (b)(4) insulin lispro (b)(4), her blood glucose was not good (values not reported), hypertension (unknown if preexisting condition worsened) and diabetes complications after taking medication, and because of these events she was hospitalized many times.She received unspecific treatment at hospital.Further details regarding hospitalization, including admission and discharge dates were not reported.In (b)(6) 2016, she did not administer insulin lispro protamine suspension (b)(4)/insulin lispro (b)(4) due to humapen luxura burgundy injection button could not be pressed down (product complaint (b)(4)/ lot 1112b01).Information regarding outcome of the events was not reported.Insulin lispro protamine suspension (b)(4)/insulin lispro (b)(4) treatment continued.The operator of the humapen luxura burgundy was the patient and her training status was not reported.The general and suspect device was started in 2013 and stopped in (b)(6)-2016.The device was returned on (b)(6) 2016.The reporting consumer did not know if the events were related to insulin lispro protamine suspension (b)(4)/insulin lispro (b)(4) or humapen device.No additional follow-up will be attempted as the reporter refused to provide additional information and no physician contact details were provided.Edit (b)(6) 2016.Case was opened to enter medwatch and update the (b)(6) device fields for device mailing.No new information.Update (b)(6) 2016: information received on (b)(6) 2016.Reporter refused to be contacted any more.Therefore, follow up information could not be pursued.Updated narrative accordingly.No other changes were performed in the case.Edit (b)(6) 2016: (b)(4) was retransmitted on (b)(6) 2016 but this pc had already processed.No further adverse event information was added.Update (b)(6) 2016: additional information received on (b)(6) 2016 from the (b)(4) product complaint database added the device specific safety summary, return date of the device, and manufactured date of the device; updated the device to a humapen luxura burgundy based on a verifiable lot number; updated the improper use and storage to yes; updated the malfunction field to yes/not cirm; updated the medwatch and (b)(6) required device reporting elements; and updated the narrative.

• Brand Name: HUMAPEN LUXURA BURGUNDY
• 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: 5543636
• MDR Text Key: 41724026
• Report Number: 1819470-2016-00082
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K142518
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 03/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MS9662
• Device Lot Number: 1112B01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2016
• Date Manufacturer Received: 04/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2011
• 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