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

Model Number MS9662

Device Problems Material Fragmentation (1261); No Audible Prompt/Feedback (2282)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This solicited case, reported by a consumer to report adverse events and a product complaint (pc) via a patient support program (psp), concerned a (b)(6) (at the time of the initial report) female patient of (b)(6).Medical histories included colitis from 37 years and she was hospitalized in 2009 because of high blood glucose and diabetes mellitus, renal failure, heart failure, colitis, intestinal hemorrhage, and sulfanilamide allergy.Family histories included her mother had diabetes mellitus and her brother and sister had sulfanilamide allergy.Drug adverse reaction history included allergic to yikean (as reported) used for lung disease.Family drug adverse reaction was none.Concomitant medication included metformin for the treatment of type ii diabetes mellitus.The patient received insulin lispro protamine suspension 75% insulin lispro 25% (rdna origin) injections (humalog mix 25, 100 units/ml) from a cartridge, via reusable pens included humapen luxura (burgundy) and humapen ergo ii, with a dose of 16 units or 20 units in the morning and 18 units or 20 units in the night, twice a day (bid), subcutaneously, for the treatment of type ii diabetes mellitus, beginning on an unknown date in 2011 and discontinued the therapy on an unknown date.The patient also received insulin lispro protamine suspension 50%/ insulin lispro 50% (rdna origin) injections (humalog mix 50, 100 units/ml) from a cartridge, via a reusable pen of humapen ergo ii, with a dose of 18 units in the morning and 18 to 20 units in the night, twice a day, subcutaneously for the treatment of type ii diabetes mellitus, beginning on (b)(6) 2018 or (b)(6) 2019 (conflicting start date was reported).On an unspecified date, the humapen ergo ii was too light and the injection speed of the humapen was too fast ((b)(4)/ lot unknown).The humapen luxura burgundy was quiet sinking, the middle part that cap connected to the body of the pen (cartridge holder trim ring) was missing ((b)(4)/ lot unknown).On an unknown date, while on insulin lispro protamine suspension 75% insulin lispro 25% therapy, her blood glucose level could not be controlled well (value, unit, and reference range were not provided) due to which she had discontinued insulin lispro protamine suspension 75% insulin lispro 25% therapy and changed to use insulin lispro protamine suspension 50%/ insulin lispro 50% therapy by medical advice on (b)(6) 2019 or (b)(6) 2019.On an unknown date, while on insulin lispro protamine suspension 75% insulin lispro 25% and insulin lispro protamine suspension 50%/ insulin lispro 50% therapies, her blood sugar was unstable (unit, reference range, and value were not provided).The patient mentioned she was hospitalized for a few times after using humalog mix 50, hospitalized once every one to two years (specific time and reason were unknown).From an unknown date, her colitis and intestinal hemorrhage were possibly aggravated as well as experienced hematochezia, and intestinal polyps.It was effect by the unspecified drug which stimulate the intestine.On (b)(6) 2020, she was hospitalized due to the events of colitis and intestinal hemorrhage were possibly aggravated and hematochezia, and intestinal polyps.As of (b)(6) 2020, she did not discharge from the hospital, and the events of blood glucose abnormal, colitis and intestinal hemorrhage were improved while the outcome of the events of hematochezia and intestinal polyps was unknown.On an unknown date, she experienced ulcerative colitis for which she was hospitalized in the middle of (b)(6) 2020 and was discharged on (b)(6) 2020.On an unknown date, she felt too tired.On an unknown date, she was hospitalized due to the complication and the blood glucose (exact values, units, and reference ranges were unknown).On an unspecified date, she was hospitalized to check her parts of the body and during the hospitalizations, the result was like the heart was getting worse, and the blood pressure was high (exact values, units, and reference ranges were unknown).On an unknown date in (b)(6) 2020, she was hospitalized last (the reason was unknown) and did not hospitalize in 2021 because of the pandemic.On an unknown date, the skin of the injection site was getting thicker and harder, like a cocoon, and the waist circumference increased (exact values, units, and reference ranges were unknown).Her injection sites on the thigh were painful when injecting at the thighs.On an unspecified date, the humapen ergo ii (blue injection pens) were bad because the injection pen could not use up all the insulin in the cartridge ((b)(4)/ lot: 1605d01), and the insulin was so expensive, she was not satisfied with it but the purple injection pen was good, she hopes that she could receive the purple injection pen ((b)(4) / lot: unknown).Further information regarding the corrective treatment and the outcome for the remaining events was unknown.It was unknown if insulin lispro protamine suspension 75% insulin lispro 25% therapy would be resumed or not and insulin lispro protamine suspension 50%/ insulin lispro 50% therapy was ongoing.The user of the humapen luxura (burgundy) ((b)(4)/lot number: unknown; (b)(4) / lot: unknown) and humapen ergo ii devices ((b)/lot number: unknown; (b)(4)/ lot:1605d01) was the patient, and her training status was not provided.The general humapen luxura (burgundy) and humapen ergo ii model duration of use were provided.The suspect humapen luxura (burgundy) and humapen ergo ii devices duration of use were not provided.The patient continued to use the humapen ergo ii and humapen luxura (burgundy) and the devices were not returned.The initial reporting consumer did not relate the events of ulcerative colitis, intestinal hemorrhage, primary episode of blood glucose abnormal and tiredness and did not report any relatedness for the remaining events with insulin lispro protamine suspension 75% insulin lispro 25% and insulin lispro protamine suspension 50%/ insulin lispro 50% therapies while as per the physician, the waist circumference increased was related to the insulin lispro protamine suspension 75% insulin lispro 25% and insulin lispro protamine suspension 50%/ insulin lispro 50% therapies.The reporting consumer thought that the unstable blood sugar was related to old age.The reporting consumer did not provide the relatedness between the events and humapen ergo ii and humapen luxura (burgundy).Update 23-jan-2019: information was received from responsible complaint person on 21-jan-2019 and product complaints were received and processed accordingly.No other changes were made to the case.Update 16-jan-2020: additional information was received from the initial reporter via a psp on 14-jan-2020.Added four medical histories of colitis, intestinal hemorrhage, sulfanilamide allergy and brother and sister had sulfanilamide allergy; laboratory values for blood glucose; additional dosage regimen of insulin lispro protamine suspension 75% insulin lispro 25% and insulin lispro protamine suspension 50%/ insulin lispro 50% therapies; conflicting start date of insulin lispro protamine suspension 50%/ insulin lispro 50% drug and two serious events of colitis and intestinal hemorrhage.Updated last name of the initial reporter and patient and initials of the patient; reported verbiage and outcome of the event blood glucose abnormal and narrative with the new information.Update 12-feb-2020: additional information was received from initial reporter via psp on 06-feb-2020.Added hospitalization discharge date.Updated description as reported and coding of event of colitis aggravated to ulcerative colitis.Updated causality statement and narrative with new information.Update 24-feb-2020: information was received via initial reporter on 14-feb-2020.No new medically significant information was added to the case.Update 31-dec-2021: additional information received from the initial reporter on 27-dec-2021 via psp.Added medical history of diabetes mellitus, blood glucose high, hospitalization in 2009, suspect devices humapen luxura burgundy and humapen ergo ii, non-serious event fatigue.Updated causality statement and narrative with new information.Update 17-jan-2022: additional information was received from the initial reporter on 12-jan-2022 via psp.The case priority was upgraded with the addition of a device qualifying serious event of blood glucose abnormal.Added lab data for blood glucose, blood pressure, and waist circumference, five serious events of intestinal polyp, hematochezia, blood glucose abnormal, heart disorder and blood pressure high, and three non-serious events of injection site induration, waist circumference increased and injection site pain.Updated suspect formulation for insulin lispro protamine suspension 75% insulin lispro 25% and insulin lispro protamine suspension 50%/ insulin lispro 50% therapies.Updated causality statement and narrative with the new information.Update 02-feb-2022: additional information received on 28-jan-2022 from the global product complaint database.Entered device specific safety summaries (dsss).Updated the medwatch fields/ (b)(6) (eu/ca) device information for (b)(4) associated with unknown lot of humapen luxura(burgundy) device and for (b)(4) with lot 1605d01 of humapen ergo ii.Added date of manufacturer for humapen ergo ii device.Corresponding fields and narrative updated accordingly.Update 23-feb-2022: additional information received on 17-feb-2022 from the global product complaint database.Entered the device specific safety summary (dsss); updated the medwatch and (b)(6) (eu/ca) device fields, and device not returned to manufacturer for the suspect humapen luxura(burgundy) device associated with (b)(4) and for the suspect humapen ergo ii devices associated with (b)(4).Corresponding fields and narrative updated accordingly.

Manufacturer Narrative

No further follow-up is planned.This report is associated with 1819470-2022-00007, 1819470-2022-00009, and 1819470-2022-00010 since there is more than one device implicated evaluation summary a female patient reported on (b)(6) 2019 that her humapen luxura device "is quiet sinking, the middle part that cap connected to the body of the pen (a silver-white circle like electroplating, which means cartridge holder trim ring) was missing, but it does not affect the use, thus no other appeal." she experienced abnormal blood glucose in (b)(6) 2020.The device was not returned to the manufacturer for investigation (batch 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 with high probability.There is no evidence of improper use or storage.

• 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: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 13635357
• MDR Text Key: 289884047
• Report Number: 1819470-2022-00008
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K142518
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• 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: 01/12/2022
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 53 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian