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

Model Number MS9662

Device Problem Improper Flow or Infusion (2954)

Patient Problem Hyperglycemia (1905)

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 adverse events and product complaints (pc), with additional information from the initial reporter, concerned a (b)(6) female patient of unknown origin.Medical history was not provided.Concomitant medications included acetylsalicylic acid, indapamide, metformin and amlodipine besilate/valsartan; all used for unknown indication.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injection (humulin m3) through cartridge via reusable pen (humapen luxura, burgundy); dosage regimen, indication for use and start date were unknown.When she picked humapen luxura up, the dose knob rotated by it and it did not stay fixed with the dose (lot 0706b01/(b)(4)).On unknown date, she had uncontrolled blood values, values were higher than normal (above 200 mg/dl).This event was considered to be serious for the pharmacist reporter; she noticed that the cartridge of human insulin 70/30 was always full and might be she was not receiving the doses of insulin and the laboratory results were not available ((b)(4)/lot number c607980).He did not have any corrective treatment and the blood glucose values returned to normal.Outcome of the drug dose omission event was unknown.The status of human insulin 70/30 was not provided.The operator of the device was the patient and her training status was unknown.The general device duration of use and the reported device duration of use were unknown.The status of the device and the action taken were unknown.The reporting pharmacist related the events to the device exclusively.Update 22-jun-2017: additional information received on 16-jun-2017 from the initial reporter.Added concomitant medications and new human insulin 70/30 lot number.Updated outcome for the blood glucose increased event from unknown to recovered and treatment received from unknown to no.Upon internal review, changed device relatedness from device nhcp to yes to reflect narrative.Narratives and fields were updated accordingly.Update 26jun2017: additional information received on 23jun2017 from global product complaint database reiterated the lot number c607980 for (b)(4) relating to the human insulin isophane suspension 70%/human insulin 30% which was already present and correct in the case.Edit 29jun2017 case was opened to enter medwatch device fields for device mailing.

Manufacturer Narrative

New updated and corrected information is referenced within the update statements.Please refer to statement dated 03aug2017.  no further follow up is planned.Evaluation summary: a pharmacist reported, on the behalf of a female patient, the dose knob of the patient's humapen luxura device rotated freely and did "not stay fixed with the dose".The patient experienced increased blood glucose levels.Investigation of the returned device (batch 0706b01, manufactured june 2007) found the device met functional requirements and met dose accuracy and glide (injection) force specifications.No malfunction was identified.There is no evidence of improper use or storage.

Event Description

Lilly case id:(b)(4).This spontaneous case, reported by a pharmacist who contacted the company to report adverse events and product complaints (pc), with additional information from the initial reporter, concerned a (b)(6) female patient of unknown origin.Medical history was not provided.Concomitant medications included acetylsalicylic acid, indapamide, metformin and amlodipine besilate/valsartan; all used for unknown indication.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injection (humulin m3) through cartridge via reusable pen (humapen luxura, burgundy); dosage regimen, indication for use and start date were unknown.When she picked humapen luxura up, the dose knob rotated by it and it did not stay fixed with the dose (lot 0706b01/pc (b)(4)).On unknown date, she had uncontrolled blood values, values were higher than normal (above 200 mg/dl).This event was considered to be serious for the pharmacist reporter; she noticed that the cartridge of human insulin 70/30 was always full and might be she was not receiving the doses of insulin and the laboratory results were not available (pc number (b)(4)/lot number c607980).He did not have any corrective treatment and the blood glucose values returned to normal.Outcome of the drug dose omission event was unknown.The status of human insulin 70/30 was not provided.The operator of the device was the patient and her training status was unknown.The general device duration of use and the reported device duration of use were unknown.The suspect device which was manufactured in jun2007 was returned to the manufacturer on 27jun2017.The reporting pharmacist related the events to the device exclusively.Update 22-jun-2017: additional information received on 16-jun-2017 from the initial reporter.Added concomitant medications and new human insulin 70/30 lot number.Updated outcome for the blood glucose increased event from unknown to recovered and treatment received from unknown to no.Upon internal review, changed device relatedness from device nhcp to yes to reflect narrative.Narratives and fields were updated accordingly.Update 26jun2017: additional information received on 23jun2017 from global product complaint database reiterated the lot number c607980 for product complaint (b)(4)relating to the human insulin isophane suspension 70%/human insulin 30% which was already present and correct in the case.Edit 29jun2017 case was opened to enter medwatch device fields for device mailing.Update 03aug2017: additional information received on 02aug2017 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch/european and (b)(6) (eu/(b)(6)) fields, malfunction from unknown to no, and device return status to returned to the manufacturer.Added date of manufacturer and date returned to manufacturer for the device associated with pc (b)(4) humapen luxura.Corresponding fields and narrative updated accordingly.

• 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: 6689089
• MDR Text Key: 79144167
• Report Number: 1819470-2017-00111
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• 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: 0706B01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2007
• 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
• Treatment: COPALIA (AMLODIPINE BESILATE, VALSARTAN); FLUDEX (INDAPAMIDE); HUMULIN 30% REGULAR, 70% NPH; METFORMIN; TROMALYT (ACETYLSALICYLIC ACID)
• Patient Outcome(s): Other
• Patient Age: 78 YR