MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN LUXURA HALF-DOSE PEN; FOR TREATMENT PURPOSES

Model Number MS9673A

Device Problems Break (1069); Device Slipped (1584); Improper or Incorrect Procedure or Method (2017)

Patient Problems Hyperglycemia (1905); Unspecified Infection (1930); Visual Impairment (2138); Anxiety (2328); Diabetic Ketoacidosis (2364)

Event Date 04/30/2015

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 compliant: pending.This spontaneous case, reported by a consumer, who contacted the company to request product information and reported an adverse event with product complaint, concerns a (b)(6) light brown female patient.The medical history included type i diabetes diagnosed on (b)(6) 2010.Concomitant medications: insulin aspart for type i diabetes treatment.The patient received human insulin nph (rdna origin) (humulin n) via humapen luxura hd, 30iu in the morning and 10 iu at night, subcutaneously, for type i diabetes treatment and beginning in (b)(6) 2010.In (b)(6) 2015, four years and 8 months after the beginning of human insulin nph treatment, the patient experienced lung infection and was hospitalized due to this event; according to consumer reporter it occurred because she was very vulnerable due to diabetes.As corrective treatment for lung infection she received an unspecified antibiotic for three days and recovered on an unspecified date.The laboratorial exams were not provided.In addition, during hospitalization, the patient experienced very high glycemia and physician decided to prolong the hospitalization; according to consumer reporter the patient was stressed and anxious in the hospital and because of this the glycemia increased a lot.The patient received an unspecified treatment for very high glycemia, the laboratorial exams were not provided and recovered from the event on an undisclosed date.The corrective treatment and the outcome for stress and anxiety were not provided.In (b)(6) 2015, the patient began to have difficulty seeing the blackboard at school; so the physician requested unspecified eye exams which showed the patient had astigmatism.As corrective treatment for astigmatism she began using glasses and the outcome was not recovered.On (b)(6) 2016, the patient experienced ketoacidosis diabetic due to wrong diet and was hospitalized due to this event; it was reported the glycosylated hemoglobin was 11 (unknown units and reference range).In the hospital, the patient received an unspecified treatment for ketoacidosis diabetic and recovered from the event on (b)(6) 2016.The corrective treatment and the outcome for glycosylated hemoglobin of 11 was not provided.On (b)(6) 2016, the patient began to have multiple episodes of hyperglycemia, the glycemic measures were: high at 7am, at 9am was 495 (unknown units and reference range), at midday was 535, at night was 390 and before bedtime was 475.On (b)(6) 2016, the fasting glycemia was 398, at lunch was high, at night was 390 and before bedtime was 475.On (b)(6) 2016, the patient started improving, the fasting glycemia was 178 and the glycemia before lunch was 118.The patient received insulin aspart for these hyperglycemic peaks and recovered on (b)(6) 2016.According to consumer reporter, the hyperglycemia was due to wrong diet on the weekend.The hyperglycemia was considered as serious by the company due to medically significant reasons.On an unspecified date, after started human insulin nph via humapen luxura hd (lot 1009g01), the injection button was broken, reported as the little spring was loose; it was necessary to remove and fit the injection button for each application in order to select the dose to be administered.The status of human insulin nph treatment was ongoing.The patients mother operated the device and no information about training was provided.The patient used this device model for unknown time and the reported device for four months.The device was available to return to the manufacturer.If device is returned, evaluation will be performed to determine if a malfunction has occurred.The consumer reporter did not relate lung infection, very high glycemia, stress, anxiety, astigmatism, ketoacidosis diabetic and episodes of hyperglycemia to human insulin nph treatment and did not provide a relatedness opinion between the remaining events and human insulin nph.The consumer reporter related the lung infection to patients vulnerability due to diabetes; related very high glycemia to stress and anxiety; related ketoacidosis diabetic and episodes of hyperglycemia to wrong diet.Update 29mar2016.Case was opened to enter medwatch and european/canadian device fields for device mailing.

Manufacturer Narrative

No further follow up is planned.Evaluation summary a mother of a female patient reported that the injection button on her daughter's humapen luxura hd device was broken and "when she turned the device upside down, the injection screw would descend by itself." she experienced increased blood glucose, diabetic ketoacidosis and hyperglycemia.The device was not returned to the manufacturer for investigation (batch 1009g01, manufactured september 2010).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review of this batch did not identify any atypical trends with regard to device is not accurate and device broken.All humapen luxura hd devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring functionality and dose accuracy.Additionally, the humapen luxura hd device is designed so that the injection screw can move freely when the device is turned up and down when no cartridge is attached.The reporter was aware that the device was broken but continued to use it by detaching and reattaching the injection button prior to each injection.The user manual states if any of the parts of your humapen luxura hd appear broken or damaged, do not use.There is evidence of improper use.The reported continued to use the device after it broke.It is unknown if this was relevant to the complaints of increased blood glucose, diabetic ketoacidosis or hyperglycemia.

Event Description

(b)(4).This report is associated with product compliant: (b)(4).This spontaneous case, reported by a consumer, who contacted the company to request product information and reported an adverse event with product complaint, concerns a (b)(6) light brown female patient.The medical history included type i diabetes diagnosed on (b)(6) 2010.Concomitant medications: insulin aspart for type i diabetes treatment.The patient received human insulin nph (rdna origin) (humulin n) via humapen luxura hd, 30iu in the morning and 10 iu at night, subcutaneously, for type i diabetes treatment and beginning in (b)(6) 2010.In (b)(6) 2015, four years and 8 months after the beginning of human insulin nph treatment, the patient experienced lung infection and was hospitalized due to this event; according to consumer reporter it occurred because she was very vulnerable due to diabetes.As corrective treatment for lung infection she received an unspecified antibiotic for three days and recovered on an unspecified date.The laboratorial exams were not provided.In addition, during hospitalization, the patient experienced very high glycemia and physician decided to prolong the hospitalization; according to consumer reporter the patient was stressed and anxious in the hospital and because of this the glycemia increased a lot.The patient received an unspecified treatment for very high glycemia, the laboratorial exams were not provided and recovered from the event on an undisclosed date.The corrective treatment and the outcome for stress and anxiety were not provided.In (b)(6) 2015, the patient began to have difficulty seeing the blackboard at school; so the physician requested unspecified eye exams which showed the patient had astigmatism.As corrective treatment for astigmatism she began using glasses and the outcome was not recovered.On (b)(6) 2016, the patient experienced ketoacidosis diabetic due to wrong diet and was hospitalized due to this event; it was reported the glycosylated hemoglobin was 11 (unknown units and reference range).In the hospital, the patient received an unspecified treatment for ketoacidosis diabetic and recovered from the event on (b)(6) 2016.The corrective treatment and the outcome for glycosylated hemoglobin of 11 was not provided.On (b)(6) 2016, the patient began to have multiple episodes of hyperglycemia, the glycemic measures were: high at 7am, at 9am was 495 (unknown units and reference range), at midday was 535, at night was 390 and before bedtime was 475.On (b)(6) 2016, the fasting glycemia was 398, at lunch was high, at night was 390 and before bedtime was 475.On (b)(6) 2016, the patient started improving, the fasting glycemia was 178 and the glycemia before lunch was 118.The patient received insulin aspart for these hyperglycemic peaks and recovered on (b)(6) 2016.According to consumer reporter, the hyperglycemia was due to wrong diet on the weekend.The hyperglycemia was considered as serious by the company due to medically significant reasons.On an unspecified date, after started human insulin nph via humapen luxura hd (lot 1009g01), the injection button was broken, reported as the little spring was loose; it was necessary to remove and fit the injection button for each application in order to select the dose to be administered ((b)(4)).The status of human insulin nph treatment was ongoing.The patients mother operated the device and no information about training was provided.The patient used this device model for unknown time and the reported device for four months.The device was available to return to the manufacturer.The device was not returned.The consumer reporter did not relate lung infection, very high glycemia, stress, anxiety, astigmatism, ketoacidosis diabetic and episodes of hyperglycemia to human insulin nph treatment and did not provide a relatedness opinion between the remaining events and human insulin nph.The consumer reporter related the lung infection to patients vulnerability due to diabetes; related very high glycemia to stress and anxiety; related ketoacidosis diabetic and episodes of hyperglycemia to wrong diet.Update 29mar2016.Case was opened to enter medwatch and european/canadian device fields for device mailing.Edit 01apr2016: upon internal review, the case was unlocked to include the pc number in the narrative.Update 25apr2016: additional information received on 25apr2016 from the global product complaint database added the device specific safety summary and manufactured date of the device; updated the improper use and storage to yes; added the device was not returned; updated the medwatch and european and canadian required device reporting elements; and updated the narrative.

• Brand Name: HUMAPEN LUXURA HALF-DOSE PEN
• 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: 5540757
• MDR Text Key: 41650620
• Report Number: 1819470-2016-00070
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K063151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MS9673A
• Device Lot Number: 1009G01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/25/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/30/2010
• 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: NOVORAPID
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 7 YR
• Patient Weight: 34