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

Model Number MS9673A

Device Problem Positioning Failure (1158)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Manufacturer Narrative

(b)(4).No further follow-up is planned.This report is associated with 1819470-2017-00133 and 1819470-2017-00135, since there is more than one device implicated.Evaluation summary: the female patient reported the injection button of her humapen luxura hd device was not releasing insulin.She also stated she had to "twist the dose selector button several times until the insulin was released." she experienced increased blood glucose.The device was not returned for investigation (batch 1312g01, manufactured december 2013).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 device functionality and dose accuracy with high probability.Troubleshooting was performed with guidance of a trained professional.The insulin was then released normally.The instructions for use state, "you must push the injection button straight down for the dose to be delivered" and "you will not receive your insulin by turning the dose knob." there is evidence of improper use.The patient may have been dialing (turning) the injection button down instead of pushing the injection button straight down.This may be relevant to the event of increased blood glucose.Refer to (b)(4) for local reporting decision.

Event Description

Lilly case id: (b)(6).This report is associated with product compliant: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report an adverse event and a product complaint, concerns a female patient, with ethnicity and age unknown.Medical history and concomitant medication were not reported.The patient received human insulin (rdna origin) nph (humulin n) and human insulin (rdna origin) regular (humulin r), cartridge, unknown dose, frequency, route of administration and treatment reason, beginning on an unspecified date.It was provided that patient had three reusable pens, one humapen luxura burgundy (lot 1205b01), one humapen luxura half dose pen (lot 1312g01) and one humapen savvio gray (lot 1406v06), but it was unclear how human insulin nph and human insulin regular were delivered if patient used both of them with the three pens or not.On an unknown date in the beginning of 2017, unknown time after beginning human insulin nph and human insulin regular, unclear if while receiving via humapen luxura burgundy (lot 1205b01), humapen luxura half dose pen (lot 1312g01) or humapen savvio gray (lot 1406v06), the patient went to the emergency care unit because her glycaemia was 580 (no units and normal ranges were provided), which was considered serious due to medically significant reasons by the company.On (b)(6) 2017, one of the three pens (it was not reported which one of them) did not release the medication when the patient was making the application of the human insulin (it was not provided if was human insulin nph or human insulin regular), so the patient needed to rotate the dosage button several times until the medication was released.On (b)(6) 2017 it was reported that the three pens humapen luxura burgundy (lot 1205b01; pc# (b)(4)), humapen luxura half dose pen (lot 1312g01; pc# (b)(4)) and humapen savvio gray (lot 1406v06; pc# (b)(4)) were with the same problem and were not releasing the medication further described as she may have not been dialing/turning the injection button down instead of pushing the injection button straight down.No information about exams, corrective treatment and outcome was provided.On (b)(6) 2017 human insulin nph and human insulin regular therapies were ongoing.The patient operated the devices and it was unknown if she was trained.The patient had used the reported humapen luxura burgundy (lot 1205b01) for more than two years which was manufactured in may2012, humapen luxura half dose pen (lot 1312g01) for about two years which was manufactured in dec2013 and humapen savvio gray (lot 1406v06) for less than a year which was manufactured in jun2014, and the three devices models for unknown time.The complaint was resolved.The devices remained in use, and would not be returned.The consumer reporter did not provide a relatedness opinion.Update 02aug2017: additional information received on 27jul2017 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and (b)(4) (eu/(b)(4)) device information, improper use and storage from no to yes, and device return status to not returned to manufacturer for devices associated with pc (b)(4).Added date of manufacturer for devices associated with pc (b)(4).Corresponding fields and narrative updated accordingly.

• 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: 6787903
• MDR Text Key: 82579294
• Report Number: 1819470-2017-00134
• 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
• Report Date: 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• 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: 1312G01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2013
• 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