MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN LUXURA, UNKNOWN PEN BODY TYPE; FOR TREATMENT PURPOSES

Model Number UNKNOWN

Device Problems Loose or Intermittent Connection (1371); Device Operates Differently Than Expected (2913)

Patient Problems Hyperglycemia (1905); Complaint, Ill-Defined (2331)

Event Type  Injury  

Manufacturer Narrative

There was no reported complaint for this device and its return is not expected.A follow-up report will be submitted when the final evaluation is completed as necessary.This report is associated with 1819470-2018-00014 since there is more than one device implicated.

Event Description

(b)(4).This spontaneous case, reported by two consumers, who contacted the company to report a product complaint and adverse events, concerns a female patient of unknown age and ethnicity.Medical history and concomitant medications were not provided.The patient received human insulin (rdna origin) nph (unknown manufacturer) and human insulin (rdna origin) regular (humulin r), both cartridges, unknown dose, frequency, route of administration, for diabetes, beginning on unknown date.Since 2013 the patient used humapen luxura unknown color (lot unknown), however, it was unclear which insulin was administered by the device.In (b)(6) 2017, unspecified time after beginning treatments with human insulin nph and human insulin regular, the patient bought a humapen luxura half-dose (lot 1403g08), which had loose injection screw foot, and for this reason, it did not release human insulin regular correctly if the selected dose was 4 iu or less, it released only drops ((b)(4)).It was reported that because the device was not injecting insulin correctly, patient s diabetes, that was uncontrolled, did not decreased, which was considered serious due to life threatening reasons by the reporter.As corrective treatment, patient was administering human insulin regular with a syringe.Information regarding laboratorial exams, blood glucose monitoring and outcome was not provided.Therapy with human insulin nph and human insulin regular was ongoing.The device needles were reutilized.The patient operated the devices and it was unknown if she was trained.The device models had been used since unspecified time.The reported humapen luxura unknown color had been used since 2013.The reported humapen luxura half-dose had been used since (b)(6) 2017.There was no reported complaint for the humapen luxura unknown color and its return was not expected.The status of return for humapen luxura half-dose was not provided.The humapen luxura unknown color was in use.The status of use of humapen luxura half-dose was not provided.No relatedness opinion was provided.Update 31jan2018: additional information received on 29jan2018 from the two consumers was processed within the initial case entry.Edit 31jan2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.

Manufacturer Narrative

Narrative field: new, updated and corrected information is referenced within the update statements in describe event or problem.Please refer to update statement dated (b)(6) 2018 in the describe event or problem field.No further follow-up is planned.This report is associated with 1819470-2018-00014 since there is more than one device implicated.Evaluation summary: a female patient reported that she had been using a humapen luxura device since 2013 and that it is working normally.It is unknown if the patient used this luxura device concomitantly with another device, with which she alleged a device issue and experienced increased blood glucose.The humapen luxura device was not returned for investigation (batch unknown) as the patient stated it was working normally.All humapen luxura devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy with high probability.There is evidence of improper use.The patient reuses needles.

Event Description

(b)(4).This spontaneous case, reported by two consumers, who contacted the company to report a product complaint (pc) and adverse events, concerns a female patient of unknown age and ethnicity.Medical history and concomitant medications were not provided.The patient received human insulin (rdna origin) nph (unknown manufacturer) and human insulin (rdna origin) regular (humulin r), both cartridges, unknown dose, frequency, route of administration, for diabetes, beginning on unknown date.Since 2013 the patient used humapen luxura unknown color, however, it was unclear which insulin was administered by the device.It was noted the lot number, manufacturer date, and expiratory date were not readable ((b)(4), lot number unknown).In (b)(6) 2017, unspecified time after beginning treatments with human insulin nph and human insulin regular, the patient bought a humapen luxura half-dose device, which had loose injection screw foot, and for this reason, it did not release human insulin regular correctly if the selected dose was 4 iu or less, it released only drops ((b)(4), lot number1403g08).It was reported that because the device was not injecting insulin correctly, patient s diabetes, that was uncontrolled, did not decreased, which was considered serious due to life threatening reasons by the reporter.As corrective treatment, patient was administering human insulin regular with a syringe.Information regarding laboratorial exams, blood glucose monitoring and outcome was not provided.Therapy with human insulin nph and human insulin regular was ongoing.The device needles were reutilized.The patient operated the devices and it was unknown if she was trained.The device models had been used since unspecified time.The reported humapen luxura unknown color had been used since 2013.The reported humapen luxura half-dose device had been used since (b)(6) 2017.The humapen luxura unknown color was in use.The suspect humapen luxura half-dose device associated with (b)(4) and the humapen luxura unknown device associated with (b)(4) were not returned to the manufacturer.No relatedness opinion was provided.Update 31jan2018: additional information received on 29jan2018 from the two consumers was processed within the initial case entry.Edit 31jan2018: updated medwatch and european and (b)(6) (eu/(b)(6)) fields for expedited device reporting.No new information added.Update 21feb2018: additional information received on 21feb2018 from the global product complaint database.Entered device specific safety summaries (dsss).Updated the medwatch fields with device information and the european and (b)(6) (eu/(b)(6)) device information.Noted the suspect humapen luxura half-dose device associated with (b)(4) and the humapen luxura (unknown body type) device associated with (b)(4) were not returned to the manufacturer.Added date of manufacturer for the humapen luxura half-dose device.Corresponding fields and narrative updated accordingly.

• Brand Name: HUMAPEN LUXURA, UNKNOWN PEN BODY TYPE
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• MDR Report Key: 7284040
• MDR Text Key: 100545524
• Report Number: 1819470-2018-00015
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening