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

Model Number MS9662

Device Problems Mechanical Jam (2983); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Hyperglycemia (1905); Missed Dose (2561)

Event Date 01/31/2015

Event Type  Injury  

Manufacturer Narrative

This report is associated with 1819470-2020-00109 since there is more than one device implicated.No further follow-up is planned.Evaluation summary a female patient reported that when using her humapen luxura in 2015 or 2016, the black injection screw did not move, injection button could not be pressed down, insulin could not be pushed out.She 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 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 complaint: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report an adverse event and product complaint (pc), concerned an (b)(6) female patient.Medical history included coronary heart disease.There were no concomitant medications.The patient received human insulin (rdna origin) injections (humulin r, 100u/ml) through cartridge via humapen luxura burgundy (purplish red) and humapen ergo ii (blue plastic), thrice daily (tid, morning 6, noon 6, evening 6) subcutaneously for the treatment of diabetes mellitus, beginning on an unknown date approximately in 1990 or 2000.She was also receiving human insulin isophane suspension (rdna origin) injections (humulin n, 100u/ml), through cartridge via humapen luxura burgundy (purplish red) and humapen ergo ii (blue plastic), once daily (od, evening 12) subcutaneously for the treatment of diabetes mellitus, beginning on an unknown date approximately in 1990 or 2000.On an unknown date approximately in 2015 or 2016, during the period of using human insulin and human insulin isophane suspension, her blood glucose was high (the blood glucose level was 12) and he was hospitalized for that for one month.She was discharged on an unknown date, further hospitalization and discharge details were not provided.The situation of high blood glucose was improving (the postprandial blood glucose was 8-9).On an unknown date, because of the malfunction of humapen luxura burgundy and humapen ergo ii, her injection of human insulin and human insulin isophane suspension was missed.The humapen luxura burgundy had malfunction in 2015 or 2016 and it was started over 10 years ago (unknown date).Further described, the black injection screw did not move, injection button could not be pressed down, insulin could not be pushed out at that moment ((b)(4), lot unknown).The humapen ergo ii had been used since 2015 or 2016.It was also noted the black injection screw did not move, injection button could not be pressed down, insulin could not be pushed out at that moment ((b)(4), lot unknown).Furthermore, on (b)(6) 2020, the black injection screw did not come out.Hotline advised her to change to a new needle, set 2 units and repeat the priming process, and priming by phone was successful.Corrective treatments were not reported.Outcome of the event high blood glucose was recovering while outcome of remaining event was unknown.Therapy with human insulin and human insulin isophane suspension were ongoing.The operator of the humapen luxura burgundy and humapen ergo ii was patient and her training status was unknown.The general duration of use for the suspect humapen luxura burgundy model was unknown, the suspect device duration of use was noted to be in over 10 years ago, approximate to 2010 (conflicting information of 10-20 years as it was started somewhere in 2000 or 2010).The general duration of use for the suspect humapen ergo ii model was unknown, the suspect device duration of use was four or five years as it was started somewhere in 2015 or 2016.The humapen luxura burgundy was discontinued in 2015 or 2016 and the patient continued to use the humapen ergo ii.Neither of the suspect devices, humapen luxura burgundy device associated with product complaint (b)(4) or the humapen ergo ii device associated with product complaint (b)(4), were returned to the manufacturer.The reporting consumer related the events with the human insulin and human insulin isophane suspension therapies.The reporting consumer related the event of missed dose to humapen luxura burgundy and humapen ergo ii while did not provide relatedness of the event high blood glucose to humapen luxura burgundy and humapen ergo ii.This case was cross-referenced with the following case number (b)(4) (same patient).Edit 24aug2020: updated medwatch and european and (b)(6) (eu/(b)(6)) fields for expedited device reporting.No new information added.Update 26aug2020: additional information received on 25aug2020 from the global product complaint database.Entered device specific safety summary (dsss), updated the medwatch fields with device information, the european and (b)(6) (eu/(b)(6)) device information, and improper use and storage from yes to no, for the suspect humapen luxura (burgundy) device associated with product complaint (b)(4), which was not returned to the manufacturer.Entered device specific safety summary (dsss), updated the medwatch fields with device information, the european and (b)(6) (eu/(b)(6)) device information, and malfunction from unknown to no for the suspect humapen ergo ii device associated with product complaint (b)(4), which was not returned to the manufacturer.Corresponding fields and narrative updated accordingly.

• Brand Name: HUMAPEN LUXURA BURGUNDY
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis, in
• Manufacturer (Section G): PHILLIPS-MEDISIZE CORPORATION; medical device manufacturing; 415 red cedar street; menomonie, wi
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, in ; 4334585
• MDR Report Key: 10459582
• MDR Text Key: 213230223
• Report Number: 1819470-2020-00108
• 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: company representative,consum
• Type of Report: Initial
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9662
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2020
• 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: 80 YR
• Patient Weight: 55