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

Model Number MS9673

Device Problem Inadequate Storage (1600)

Patient Problems Fainting (1847); Hyperglycemia (1905); Malaise (2359)

Event Type  Injury  

Manufacturer Narrative

This report is associated with product complaint: (b)(4).This is an initial report.A follow-up report will be submitted when the final evaluation is compeleted.

Event Description

Lilly case id: (b)(4).This solicited case reported by a consumer who contacted the company via a patient support program (psp) concerns a (b)(6) female patient of unknown origin.Medical history was not provided.Concomitant medications included: insulin glargine.The patient received insulin lispro (humalog) cartridge, subcutaneously, 1.5iu at breakfast, 2iu at lunch, 2iu at dinner and additional doses to correct the patient blood glucose levels if needed, for type i diabetes mellitus, beginning in (b)(6) 2015.On an unknown date, as reported as approximately in (b)(6) 2015, whilst on insulin lispro treatment via humapen luxura half-dose (batch number not provided and pc number: (b)(4)), the reporter stated that the new insulin lispro vials (batch: not provided) the patient was using were not making effect and the patient blood glucose was not reducing.The reporter noted than that the patient refrigerator was not working very well and due that the patient discarded the insulins and acquired a new box (batch: (b)(4)).The reporting consumer stated that the on an unknown date, the patient was experiencing hyperglycemia with blood glucose of 600 (no units provided) and that was not lowering by any means, the reporter stated that the patient used 12iu of insulin lispro but it did not make any effect.The reporting consumer also stated that due the hyperglycemia the patient was not feeling well and almost fainted.As corrective treatment the patient received a dose of insulin glulisine.The hyperglycemia was considered serious by the company due medically significant reasons.After the insulin glulisine dose the patient blood glucose normalized (values were not provided) and the patient recover from the hyperglycemia.It was unknown if the patient recover from the feeling bad and almost fainted events.Insulin lispro treatment status was not provided.It was unknown who was the device operator; nevertheless the operator was properly trained by an educator.The patient uses the suspect device and the suspect device model for four months.The status of the device was not provided.The reporting consumer did not provide any relatedness opinion.Update 21sep2015: upon review of this case, the case was opened to update the medwatch and eu/ca fields for regulatory reporting.The preliminary comments were updated.Update 23sep2015: additional information received on (b)(6) 2015 from the product complain area, no clinically significant information was added to the case.Update 30sep2015: additional information received on (b)(6) 2015 from the quality area, no clinically significant information was added to the case.

Manufacturer Narrative

No further follow up is planned.Evaluation summary the mother of a patient reported that her daughter experienced hyperglycemia when using a humapen luxura hd device.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 hd devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring pen functionality and dose accuracy.The reporter noted that the patient's refrigerator was not working very well, and due that the patient discarded the insulin and acquired a new box.There is no evidence of improper use or storage.

Event Description

(b)(4).This solicited case reported by a consumer who contacted the company via a patient support program (psp) concerns a (b)(6) female patient of unknown origin.Medical history was not provided.Concomitant medications included: insulin glargine.The patient received insulin lispro (humalog) cartridge, subcutaneously, 1.5iu at breakfast, 2iu at lunch, 2iu at dinner and additional doses to correct the patient blood glucose levels if needed, for type i diabetes mellitus, beginning in (b)(6) 2015.On an unknown date, as reported as approximately in (b)(6) 2015, whilst on insulin lispro treatment via humapen luxura half-dose (batch number not provided and pc number: (b)(4)), the reporter stated that the new insulin lispro vials (batch: not provided) the patient was using were not making effect and the patient blood glucose was not reducing.The reporter noted than that the patient refrigerator was not working very well and due that the patient discarded the insulins and acquired a new box (batch: c383070d).The reporting consumer stated that the on an unknown date, the patient was experiencing hyperglycemia with blood glucose of 600 (no units provided) and that was not lowering by any means, the reporter stated that the patient used 12iu of insulin lispro but it did not make any effect.The reporting consumer also stated that due the hyperglycemia the patient was not feeling well and almost fainted.As corrective treatment the patient received a dose of insulin glulisine.The hyperglycemia was considered serious by the company due medically significant reasons.After the insulin glulisine dose the patient blood glucose normalized (values were not provided) and the patient recover from the hyperglycemia.It was unknown if the patient recover from the feeling bad and almost fainted events.Insulin lispro treatment status was not provided.It was unknown who was the device operator; nevertheless the operator was properly trained by an educator.The patient uses the suspect device and the suspect device model for four months.The device was not returned.The reporting consumer did not provide any relatedness opinion.Update 21sep2015: upon review of this case, the case was opened to update the medwatch and eu/ca fields for regulatory reporting.The preliminary comments were updated.Update 23sep2015: additional information received on 21sep2015 from the product complain area, no clinically significant information was added to the case.Update 30sep2015: additional information received on 25sep2015 from the quality area, no clinically significant information was added to the case.Update 22oct2015: additional information received on 22oct2015 from the global product complaint database added the device specific safety summary; added the device was not returned; updated the medwatch and eu/ca fields; 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: 5116176
• MDR Text Key: 27479127
• Report Number: 1819470-2015-00096
• 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: company representative,consum
• Type of Report: Followup
• Report Date: 09/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MS9673
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other
• Patient Age: 7 YR