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

Model Number MS9662

Device Problems Failure to Deliver (2338); Device Operates Differently Than Expected (2913)

Patient Problems Weakness (2145); Urinary Frequency (2275); Polydipsia (2604)

Event Date 09/25/2015

Event Type  Injury  

Manufacturer Narrative

If device is returned, evaluation will be performed to determine if a malfunction has occurred.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 product complaint, concerns a (b)(6) caucasian female patient.Medical history and concomitant medication were not provided.The patient received human insulin (rdna origin) nph (humulin n), 26 iu in the morning, 20 iu at lunch and 14 iu in the evening; and human insulin (rdna origin) regular (humulin r), unknown formulation; 4 iu when dose was over 300 (units and range not provided); both subcutaneously, indicated for treatment of diabetes type i, starting on an unknown date.Approximately on (b)(6) 2015, the patient starting receiving human insulin nph via humapen luxura burgundy, batch number (b)(4), and received human insulin regular via syringe.On (b)(6) 2015, after starting treatment with human insulin nph via humapen luxura burgundy and human insulin regular, the patient thought she was receiving human insulin nph via this device, but she did not, because humapen luxura was not ejecting this insulin due to injection screw that was not touching the cartridge plunger ((b)(4)).Due to not receiving the human insulin nph dose, the patient experienced weakness, drunk a lot of water and did a lot pee.As corrective treatment the patient was admitted to the hospital and remained hospitalized for three days.The corrective treatment received was not provided.On (b)(6) 2015, the patient was discharged from hospital and recovered from weakness, drunk a lot of water and did a lot pee.As of (b)(6) 2015, the patient recovered from the event of drug dose omission.The patient never primed the pen; however, she stored it at room temperature and never reused needles.The human insulin nph and human insulin r was continued.The patient was the operator and the training status was not provided.The device model and the complained device had been used for one week.The device was expected to return.If device is returned, evaluation will be performed to determine if a malfunction has occurred.The reporting consumer related the events of weakness, drunk a lot of water, did a lot pee and drug dose omission to human insulin nph and humapen luxura device.Edit 29oct2015: upon review on information of (b)(6) 2015, added suspect device on case.Amended device information on case narrative.Update 29oct2015: additional information provided by call center on 19oct2015.Added information regarding the return of device and updated preliminary comments.Narrative and corresponding fields were updated.Edit 13nov2015: upon internal review on information of (b)(6) 2015, change priority of the case, change the device relatedness for the events of weakness, polydipsia and polyuria, completed eu/ca field and updated the as reported term of drug dose omission.Update 13nov2015: upon internal review, this case was opened to update the medwatch fields for regulatory reporting.

Manufacturer Narrative

New, updated and corrected information is referenced within the update statements.Please refer to update statement dated 07dec2015 in the field.No further follow up is planned.Evaluation summary: a female patient reported that the injection screw that was not touching the cartridge plunger of her humapen luxura device and it was not ejecting insulin.She experienced asthenia, polydipsia, and polyuria.The investigation of the returned device (batch 1401b08, manufactured january 2014) found that the device met functional requirements and met dose accuracy and glide (injection) force specifications.No malfunction was identified.The user manual provides the proper steps for priming the device which will remove the gap between the screw and the cartridge plunger.The user manual states, "there may be a gap between the screw and the cartridge plunger.Repeating the priming steps will move the screw out to touch the cartridge plunger.Once the end of the screw pushes the cartridge plunger out, insulin will flow from the needle." the complaints expressed by the reporter are consistent with not priming the device as described in the user manual.There is evidence of improper use.The patient did not prime the device.This may be relevant to the patient's complaint.

Event Description

Lilly case id: (b)(4).This spontaneous case, reported by a consumer, who contacted the company to report an adverse event and product complaint, concerns a (b)(6) caucasian female patient.Medical history and concomitant medication were not provided.The patient received human insulin (rdna origin) nph (humulin n), 26 iu in the morning, 20 iu at lunch and 14 iu in the evening; and human insulin (rdna origin) regular (humulin r), unknown formulation; 4 iu when dose was over 300 (units and range not provided); both subcutaneously, indicated for treatment of diabetes type i, starting on an unknown date.Approximately on (b)(6) 2015, the patient starting receiving human insulin nph via humapen luxura burgundy, batch number (b)(4), and received human insulin regular via syringe.On 25sep2015, after starting treatment with human insulin nph via humapen luxura burgundy and human insulin regular, the patient thought she was receiving human insulin nph via this device, but she did not, because humapen luxura was not ejecting this insulin due to injection screw that was not touching the cartridge plunger ((b)(4)).Due to not receiving the human insulin nph dose, the patient experienced weakness, drunk a lot of water and did a lot pee.As corrective treatment the patient was admitted to the hospital and remained hospitalized for three days.The corrective treatment received was not provided.On (b)(6) 2015, the patient was discharged from hospital and recovered from weakness, drunk a lot of water and did a lot pee.As of (b)(6) 2015, the patient recovered from the event of drug dose omission.The patient never primed the pen; however, she stored it at room temperature and never reused needles.The human insulin nph and human insulin r was continued.The patient was the operator and the training status was not provided.The device model and the complained device had been used for one week.The device was returned on (b)(6) 2015, and no malfunction was found.The reporting consumer related the events of weakness, drunk a lot of water, did a lot pee and drug dose omission to human insulin nph and humapen luxura device.Edit (b)(6) 2015: upon review on information of (b)(6) 2015, added suspect device on case.Amended device information on case narrative.Update 29oct2015: additional information provided by call center on (b)(6) 2015.Added information regarding the return of device and updated preliminary comments.Narrative and corresponding fields were updated.Edit 13nov2015: upon internal review on information of (b)(6) 2015, change priority of the case, change the device relatedness for the events of weakness, polydipsia and polyuria, completed eu/ca field and updated the as reported term of drug dose omission.Update 13nov2015: upon internal review, this case was opened to update the medwatch fields for regulatory reporting.Update 07dec2015: additional information received on (b)(6) 2015 from the global product complaint database added the device specific safety summary, the return date of the device, and the manufactured date of the device; updated the improper use and storage to yes; updated the malfunction field to no; updated the medwatch and (b)(4) and (b)(4) required device reporting elements; and updated the narrative.

• 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: 5238576
• MDR Text Key: 31701749
• Report Number: 1819470-2015-00111
• 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: 09/28/2015

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: Lay User/Patient
• Device Model Number: MS9662
• Device Lot Number: 1401B08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2015
• Initial Date Manufacturer Received: 09/28/2015
• Initial Date FDA Received: 11/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2014
• 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: 19 YR
• Patient Weight: 53