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

Model Number MS9673A

Device Problems Excess Flow or Over-Infusion (1311); Inaccurate Delivery (2339)

Patient Problem Hypoglycemia (1912)

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 pharmacist who contacted the company to report an adverse event and a product complaint (pc), concerned a (b)(6) female patient of unknown origin.Medical history and concomitant medications were not reported.The patient received human insulin (rdna origin) injections (humulin r) through an unknown formulation via reusable pens (humapen luxura hd) and humapen luxura, 4-10 iu subcutaneously for the treatment of type two diabetes.Start date and frequency were not reported.She also received human insulin isophane suspension (rdna origin) injections (humulin nph) through an unknown formulation via a reusable pen (humapen luxura hd) and humapen luxura subcutaneously for the treatment of type two diabetes.Dose, frequency and start date were not reported.On an unspecified date while on human insulin and human insulin isophane suspension she developed life-threatening hypoglycaemia because her humapen luxura hd was injecting double dosage, so she injected too much insulin.Information regarding outcome of the events, corrective treatment and human insulin and human insulin isophane suspension treatment status was not provided.The patient was the operator of the humapen luxura hd and her training status was unknown.The general humapen luxura hd duration of use was not reported.The suspect humapen luxura hd duration of use was of approximately six weeks.The action taken with the device was unknown.The reporting pharmacist did not provide an assessment of relatedness between the events and human insulin, human insulin isophane suspension or the humapen luxura hd.No follow-up would be requested since the reporter refused to provide more information.Treating physician contact details not provided.Update 15aug2016: upon review, this case was opened to update the medwatch fields for regulatory reporting.

Manufacturer Narrative

(b)(4).No further follow up is planned.

Event Description

Lilly case id: (b)(4).This spontaneous case, reported by a pharmacist who contacted the company to report an adverse event and a product complaint (pc), concerned a (b)(6) female patient of unknown origin.Medical history and concomitant medications were not reported.The patient received human insulin (rdna origin) injections (huminsulin r) through an unknown formulation via reusable pens (humapen luxura hd) and humapen luxura, 4-10 iu subcutaneously for the treatment of type two diabetes.Start date and frequency were not reported.She also received human insulin isophane suspension (rdna origin) injections (huminsulin nph) through an unknown formulation via a reusable pen (humapen luxura hd) and humapen luxura subcutaneously for the treatment of type two diabetes.Dose, frequency and start date were not reported.On an unspecified date while on human insulin and human insulin isophane suspension she developed life-threatening hypoglycaemia because her humapen luxura hd was injecting double dosage, so she injected too much insulin.Information regarding outcome of the events, corrective treatment and human insulin and human insulin isophane suspension treatment status was not provided.The patient was the operator of the humapen luxura hd and her training status was unknown.The general humapen luxura hd duration of use was not reported.The suspect humapen luxura hd duration of use was of approximately six weeks.The device was returned on 16sep2016, and no malfunction was found.The reporting pharmacist did not provide an assessment of relatedness between the events and human insulin, human insulin isophane suspension or the humapen luxura hd.No follow-up would be requested since the reporter refused to provide more information.Treating physician contact details not provided.Update 15aug2016: upon review, this case was opened to update the medwatch fields for regulatory reporting.Update 08nov2016: additional information received on 08nov2016 from the global product complaint database added the device specific safety summary, the manufactured date of the device, and return date of the device; updated the malfunction field to no; updated the medwatch and european and (b)(4) required device reporting elements; 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: 5906485
• MDR Text Key: 53116115
• Report Number: 1819470-2016-00220
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9673A
• Device Lot Number: 1510G01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2016
• Date Manufacturer Received: 11/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2015
• 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): Life Threatening
• Patient Age: 70 YR