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

Model Number MS9662

Device Problem Device Inoperable (1663)

Patient Problem Hyperglycemia (1905)

Event Date 11/23/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).If device is returned, evaluation will be performed to determine if a malfunction has occurred.A report will be submitted when the final evaluation has been completed.

Event Description

Lilly case id: (b)(4) this report is associated with product compliant: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) female patient.Medical history was not provided.Concomitant medications were unknown.The patient received insulin lispro protamine 50%/insulin lispro 50% (rdna origin) (humalog mix 50) from a cartridge via a reusable pen (hp luxura burgundy), 12 units twice a day (morning and evening), subcutaneously for the treatment of diabetes mellitus beginning sometime in 2010.On an unspecified date in (b)(6) 2015, she found injection pen button was hard to press; however, she still used the injection pen ((b)(4)).On (b)(6) 2015, her blood glucose (bg) increased to 24 (units and reference values were not provided), which was possibly due to a problem with the injection pen; insulin lispro protamine 50%/insulin lispro 50% was not injected into the body.On an unspecified date in (b)(6) 2015, she was admitted into hospital to receive an unspecified treatment.On (b)(6) 2015, while she was hospitalized, the resident physician switched her from insulin lispro protamine 50%/insulin lispro 50% to insulin lispro (humalog) from a cartridge, 10 units in the morning and 8 units at noon and at night, subcutaneously.As of (b)(6) 2015, she remained hospitalized.Outcome of the events was unknown.Insulin lispro therapy was continued.The patient was the operator of the hp luxura burgundy and her training status was not provided.The general hp luxura burgundy duration of use and the suspect hp luxura burgundy duration of use was around five years.If hp luxura burgundy was returned, evaluation would be performed to determine if a malfunction had occurred.The reporting consumer had no idea if the reported events were associated to insulin lispro protamine 50%/insulin lispro 50% or to the pen injection malfunction.No additional follow-up will be attempted as the reporter declined to did not accept further follow-up and treating physician contact details were not available.Update 07-dec-2015: upon review of this case, the case was opened to update the medwatch fields for regulatory reporting.Edit 10-dec-2015: upon confirmation of internal communication; updated humapen unknown body type to hp luxura burgundy.Pc (b)(4) was processed accordingly.Updated narrative accordingly.Edit 10-dec-2015: upon internal review, pc (b)(4) was added in the narrative.

Manufacturer Narrative

If device is returned, evaluation will be performed to determine if a malfunction has occurred.New, updated and corrected information is referenced within the update statements.Please refer to update statement dated 21dec2015 in the b.5 field.No further follow up is planned.Evaluation summary a female patient reported that the injection button on her humapen luxura device could not be pushed down.She experienced increased blood glucose.The device was not returned to the manufacturer for investigation (batch (b)(4), manufactured october 2009).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review of this batch did not identify any atypical trends with regard to injection force high.There is no evidence of improper use or storage.

Event Description

(b)(4) this solicited case, reported by a consumer via a patient support program (psp), (b)(6) asian female patient.Medical history was not provided.Concomitant medications were unknown.The patient received insulin lispro protamine 50%/insulin lispro 50% (rdna origin) (humalog mix 50) from a cartridge via a reusable pen (hp luxura burgundy), 12 units twice a day (morning and evening), subcutaneously for the treatment of diabetes mellitus beginning sometime in 2010.On an unspecified date in (b)(6) 2015, she found injection pen button was hard to press; however, she still used the injection pen (3513900/0910b04).On (b)(6) 2015, her blood glucose (bg) increased to 24 (units and reference values were not provided), which was possibly due to a problem with the injection pen; insulin lispro protamine 50%/insulin lispro 50% was not injected into the body.On an unspecified date in (b)(6) 2015, she was admitted into hospital to receive an unspecified treatment.On (b)(6) 2015, while she was hospitalized, the resident physician switched her from insulin lispro protamine 50%/insulin lispro 50% to insulin lispro (humalog) from a cartridge, 10 units in the morning and 8 units at noon and at night, subcutaneously.As of (b)(6) 2015, she remained hospitalized.Outcome of the events was unknown.Insulin lispro therapy was continued.The patient was the operator of the hp luxura burgundy and her training status was not provided.The general hp luxura burgundy duration of use and the suspect hp luxura burgundy duration of use was around five years.The device was not returned.The reporting consumer had no idea if the reported events were associated to insulin lispro protamine 50%/insulin lispro 50% or to the pen injection.No additional follow-up will be attempted as the reporter declined to did not accept further follow-up and treating physician contact details were not available.Update 07-dec-2015: upon review of this case, the case was opened to update the medwatch fields for regulatory reporting.Edit 10-dec-2015: upon confirmation of internal communication; updated humapen unknown body type to hp luxura burgundy.Pc 3513900 was processed accordingly.Updated narrative accordingly.Edit 10-dec-2015: upon internal review, pc 3513900 was added in the narrative.Update 21-dec-2015: additional information received on 21-dec-2015 from the global product complaint database added the device specific safety summary and manufactured date of the device; added the device was not returned; updated the medwatch and european and canadian required device reporting elements fields; 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: 5292968
• MDR Text Key: 33477923
• Report Number: 1819470-2015-00116
• 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: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 11/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2015
• 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: 0910B04
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2009
• 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: 45 YR
• Patient Weight: 70