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

Model Number MS9662

Device Problem Application Program Problem: Dose Calculation Error (1189)

Patient Problems Blurred Vision (2137); Visual Impairment (2138); Weakness (2145); Sleep Dysfunction (2517)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

(b)(4).This spontaneous case, reported by a consumer who contacted the company to report an adverse event and a product complaint (pc), concerned a (b)(6) male patient of unspecified origin.Medical history was not provided.Concomitant medications included acarbose for unknown indication.The patient received insulin lispro protamine suspension 75%/ insulin lispro 25% (rdna origin) injections (humalog mix25) via reusable pen (humapen luxura and humapen unknown), subcutaneously, 24 unspecified units each morning and 20 unspecified units each evening for treatment of diabetes mellitus beginning approximately in 2012.On (b)(6) 2016, four years after starting insulin lispro protamine suspension 75%/ insulin lispro 25%, it was reported that the injection dosage of unspecified humapen unknown device was not accurate and he was hospitalized because his blood glucose was not good (blood glucose was being adjusted and was also reported as reason for hospitalization); also he was hospitalized because he could not eat things, insomnia, weakness and eyes blurred.Outcome for the events was unknown.Information regarding corrective treatments and details on hospitalization was not provided.Insulin lispro protamine suspension 75%/ insulin lispro 25% treatment status was ongoing.The user of the humapen unknown and its training status was not provided.The humapen unknown model duration of use and the suspect humapen unknown duration of use were not reported.The action taken with the suspect humapen unknown was not provided and its return status was not provided.The reporting consumer did not know if the events were related to insulin lispro protamine suspension 75%/ insulin lispro 25% and did not provide a relatedness assessment for the humapen.Update 15sep2016: upon review, this case was opened to update the medwatch fields for regulatory reporting.

Manufacturer Narrative

Narrative field; new updated and corrected information is referenced within the update statements.Please refer to statement dated 11oct2016 in the field.Evaluation summary the male patient reported that the injection screw of his humapen luxura device would not move out, insulin leaked from the needle after injection and the device not accurate.The patient experienced abnormal blood glucose.The device was not returned for investigation (batch number 1011b02, manufactured november 2010).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review for the batch did not identify any atypical trends with regard to injection screw not moving, leaking after injection from device or dose accuracy.All humapen luxura devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy 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 spontaneous case, reported by a consumer who contacted the company to report an adverse event and a product complaint (pc), concerned a (b)(6) -year old male patient of unspecified origin.Medical history was not provided.Concomitant medications included acarbose for unknown indication.The patient received insulin lispro protamine suspension 75%/ insulin lispro 25% (rdna origin) injections (humalog mix25) via reusable pen (humapen luxura) (lot 1011b02/pc 3767189), subcutaneously, 24 unspecified units each morning and 20 unspecified units each evening for treatment of diabetes mellitus beginning approximately in 2012.In 2015, approximately three years after starting insulin lispro protamine suspension 75%/ insulin lispro 25, it was reported that the dose administered with humapen luxura was inaccurate (conflicting information also reported as humapen innacurate and as cause of the events of (b)(6) 2016).Four years after starting insulin lispro protamine suspension 75%/ insulin lispro 25%, humapen luxura screw could not move out and he was hospitalized because his blood glucose was not good (blood glucose was being adjusted and was also reported as reason for hospitalization).Also he was hospitalized because he could not eat things, insomnia, weakness and eyes blurred.Outcome for the events was unknown.Information regarding corrective treatments and details on hospitalization was not provided.Insulin lispro protamine suspension 75%/ insulin lispro 25% treatment status was ongoing.The user of the humapen luxura and its training status was not provided.The humapen luxura model duration of use and the suspect humapen luxura duration of use were not reported.The action taken with the suspect humapen luxura was not provided and its return status was not provided.The reporting consumer did not know if the events were related to insulin lispro protamine suspension 75%/ insulin lispro 25% and did not provide a relatedness assessment for the humapen luxura.The reporting consumer did not provide an opinion of relatedness between the incorrect dose administered event and insulin lispro protamine suspension 75%/ insulin lispro 25% or humapen luxura.Update 15-sep-2016: upon review, this case was opened to update the medwatch fields for regulatory reporting.Edit 03-oct-2016: upon review of information received on 08-sep-2016 with product complaint report, an event of incorrect dose administered was added and concomitant humapen luxura burgundy was deleted.Suspect humapen unknown was recoded to humapen luxura burgundy; product complaint was processed.Narrative and fields were updated accordingly.Update 11-oct-2016.Additional information received 11-oct-2016 from the product complaint safety database.To the device tab added the manufacture date, device approximate age, added the device specific safety summary (dsss), updated the european and canadian (eu/ca) device information, updated the device medwatch information, and the narrative was updated accordingly.Update 18-oct-2016: information received from the (b)(4) on 09-sep-2016.Product complaint reference number was received, nevertheless the product complaint was already processed.No further information was received.

• 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; medical device manufacturing; 415 red cedar street; menomonie WI 54751
• Manufacturer Contact: caroline rosewell ; lilly corporate center; indianapolis, IN 46285 ; 3172764376
• MDR Report Key: 5993280
• MDR Text Key: 56186016
• Report Number: 1819470-2016-00254
• 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: 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MS9662
• Device Lot Number: 1011B02
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2010
• 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
• Treatment: HP LUXURA BURGUNDY PEN; HUMALOG LISPRO
• Patient Outcome(s): Hospitalization
• Patient Age: 50 YR
• Patient Weight: 76