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

Model Number MS9673A

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Hypoglycemia (1912); Injury (2348)

Event Date 02/06/2019

Event Type  Injury  

Manufacturer Narrative

No further follow-up is planned.Evaluation summary : the mother of the patient stated that she cut the kwikpen device to remove the cartridge and used the cartridge in a humapen luxura half-dose (hd) device.There was no product complaint for the device, and the device was not returned for investigation.There was evidence of improper use of the device, in that the reporter cut a kwikpen to remove the cartridge and used it in a humapen luxura hd device.The humapen luxura hd core label states for use only with lilly 3 ml insulin cartridges (100 iu/ml or units/ml).Do not use other brands of insulin cartridges.Although a 3 ml cartridge is contained within the kwikpen (a disposable drug/device combination product), cutting a kwikpen to remove the cartridge may damage/crack the cartridge.

Event Description

Lilly case id: (b)(4).This report is associated with product compliant: n/a.This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) year-old female patient of unknown origin.Medical history and concomitant medications were not provided.Patient received insulin lispro (humalog) via pre-filled device, unknown dose, frequency, route of administration, indication and start date.It was stated that patients mother cut kwikpen device to remove the cartridge and uses this cartridge in a humapen luxura half dose.On 06feb2019, unspecified time after starting insulin lispro via humapen luxura, patient underwent a glucose test at 09 p.M., and the result was 380.At 00 a.M., another glucose test was performed and the result showed 55 (units and ranges were not provided).Hypoglycemia was considered serious by the company due to medically significant reasons.On unknown date, patient moved the arm while injecting the insulin and she got a injury.Corrective treatments were not provided.It was also reported that on unknown date, the insulin was too hot and the temperature in that day reached 34 degree celsius, so the insulin was placed in a isolant box with ice, it was unclear if the patient used the insulin after that.Outcome for the adverse events was not provided.Status for insulin lispro was unknown.It was unknown who operates the device and if the operator received training from internal educator.It was unknown how long the patient has been using this device model and reported device.Non information about the return of the device was reported.The consumer reporter did not provide any opinion of relatedness.Edit 15feb2019: upon internal review, it was recoded the suspect reusable device for a most appropriated one, since the lot number was not provided.It was also added updated device name in the narrative.Update 15feb2019: updated medwatch and european and (b)(4) fields for expedited device reporting.Entered a device specific safety summary (dsss) for the humapen luxura hd.Corresponding fields and narrative updated accordingly.Edit 22feb2019: upon internal review, it was coded the event of blood glucose increased as non-serious event.Update 22feb2019: additional information received on 21feb2019 from the global product complaint database.Entered updated device specific safety summary (dsss).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: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 8370343
• MDR Text Key: 137285435
• Report Number: 1819470-2019-00017
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K100988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9673A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/06/2019
• 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): Other
• Patient Age: 1 YR