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

Model Number MS9662

Device Problems Break (1069); Fluid/Blood Leak (1250); Device Dislodged or Dislocated (2923)

Patient Problems Hyperglycemia (1905); No Code Available (3191)

Event Date 10/31/2019

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.This report is associated with 1819470-2019-00221 and 1819470-2019-00222 since there is more than one device implicated.

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 an (b)(6) year-old (at the time of initial report) female patient of an unknown origin.Medical history included type i diabetes and historical medication included unspecified insulin since 2004.Concomitant medications included levothyroxine sodium and tocopherol for an unknown indication.The patient received insulin lispro (rdna origin) injections (humalog 100u/ml) from cartridge via reusable pens (humapen luxura burgundy and humapen luxura half-dose), subcutaneously, for the treatment of diabetes mellitus, beginning in 2009.Dosage regimen was not provided and was changed according to carbohydrate diet.In 2016, after starting insulin lispro therapy, she had pancreatitis.On (b)(6) 2019, she bought three packages of insulin lispro cartridges.She suffered from drug ineffectiveness (product complaint number (b)(4)/lot number d062140f).In (b)(6) 2019, her blood glucose did not decreased because some of cartridges were ineffective and some were broken.On an unknown date, her blood glucose level increased to 500-600 (units and baseline values not provided).Reportedly, she was applied 22iu of insulin lispro but it was ineffective.They had nine insulin lispro cartridges and aluminum foil of the cartridges were never touched, cartridges plugs were dislocated and fluid was leaking.The events of pancreatitis and blood glucose increased were considered as serious due to their medical significance.Reportedly, on an unknown date, the black piston in the humapen luxura half-dose pen was broken (pc number (b)(4)/ lot number 1411g06) and two humapen luxura burgundy devices had pressing difficulty (pc (b)(4)/ lot number 1206b01) (pc (b)(4)/ lot number 1203b01).Information regarding corrective treatments, outcome for the events and insulin lispro treatment status was unknown.The mother of the patient was the operator of the humapen luxura burgundy devices and the humapen luxura half-dose device and her training status was not provided.The humapen luxura burgundy devices and the humapen luxura half-dose device model duration of use were not provided.For both the humapen luxura burgundy device and the humapen luxura half-dose the device general model duration of use was not provided, but both suspect devices humapen luxura burgundy lot number 1206b01, 1203b01 and humapen luxura half-dose device lot 1411g06 were started more than two years from the time of initial report.The suspect devices humapen luxura burgundy lot number 1206b01, 1203b01 and humapen luxura half-dose device lot 1411g06 were returned to the manufacturer on an unspecified date.The reporting consumer did not provide an opinion of relatedness of events with insulin lispro treatment or the humapen luxura burgundy and humapen luxura half-dose devices.Update 02-dec-2019: information received on 25-nov-2019 and 26-nov-2019 were processed together.Update 10dec2019: additional information received on 09dec2019 from global product complaint database.Recoded the suspect humapen luxura hd (model ms9673) to a humapen luxura hd (model ms9673a).Updated the lot number from unknown to 1411g06 for product complaint (b)(4) relating to the humapen luxura hd device.Recoded humapen luxura, unknown pen body type to humapen luxura burgundy.Updated the lot number from unknown to 1206b01 for product complaint (b)(4) relating to the humapen luxura burgundy device.Corresponding fields and narrative updated accordingly.Edit 12-dec-2019: upon review of the case, operator of the device was updated to mother from other (unknown) and training status of the operator was added in the narrative.No other changes were made to the case.Edit 12dec2019: updated medwatch fields for expedited device reporting.No new information added.Update 12-dec-2019: additional information received on 09-dec-2019 via responsible complaint person (rcp).Suspect products were returned to the manufacturer.Suspect products insulin lispro cartridge with lot number d062140f, humapen luxura hd with lot number 1411g06 and humapen luxura with lot number 1206b01 were confirmed.A new humapen luxura lot number 1203b01 was also returned, reported and considered as suspect.A new suspect humapen luxura burgundy with batch number 1203b01 was added to the case.Pc (b)(4) was provided, processed and added to the narrative.Corresponding fields and narrative updated accordingly.

Manufacturer Narrative

B.5.Narrative field: new, updated and corrected information is referenced within the update statements in b.5.Please refer to update statement(s) dated 16jan2020 in the b.5.Field.No further follow-up is planned.This is a downgrade report, which no longer meets the criteria for expedited reporting.This report is associated with 1819470-2019-00221 and 1819470-2019-00222 since there is more than one device implicated.Evaluation summary: the mother of a female patient reported that the patient's humapen luxura device was difficult to press.The patient experienced increased blood glucose.Investigation of the returned device (batch 1203b01, manufactured march 2012) found the device met functional requirements and met dose accuracy and glide (injection) force specifications.No malfunction was identified.The investigation also found some visual defects due to field damage (not related to the manufacturing process) that did not impact the functionality of the device.The core instructions for use provide proper care and storage instructions.The reporter also stated that of three boxes of cartridges purchased, some were broken and some were ineffective.No insulin cartridges were returned for investigation; however, a batch record review did not identify any atypical findings.There is no evidence of improper use or storage.

Event Description

Lilly case id: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned an 18-year-old (at the time of initial report) female patient of an unknown origin.Medical history included type i diabetes and historical medication included unspecified insulin since 2004.Concomitant medications included levothyroxine sodium and tocopherol for an unknown indication.The patient received insulin lispro (rdna origin) injections (humalog 100u/ml) from cartridge via reusable pens (humapen luxura burgundy and humapen luxura half-dose), subcutaneously, for the treatment of diabetes mellitus, beginning in 2009.Dosage regimen was not provided and was changed according to carbohydrate diet.In 2016, after starting insulin lispro therapy, she had pancreatitis.On (b)(6)2019, she bought three packages of insulin lispro cartridges.She suffered from drug ineffectiveness (product complaint number (b)(4)/lot number d062140f).In (b)(6)2019, her blood glucose did not decreased because some of cartridges were ineffective and some were broken.On an unknown date, her blood glucose level increased to 500-600 (units and baseline values not provided).Reportedly, she was applied 22iu of insulin lispro but it was ineffective.They had nine insulin lispro cartridges and aluminum foil of the cartridges were never touched, cartridges plugs were dislocated and fluid was leaking.The events of pancreatitis and blood glucose increased were considered as serious due to their medical significance.Reportedly, on an unknown date, the black piston in the humapen luxura half-dose pen was broken (pc number (b)(4)/ lot number 1411g06) and two humapen luxura burgundy devices had pressing difficulty (pc(b)(4)/ lot number 1206b01) (pc (b)(4)/ lot number 1203b01).Information regarding corrective treatments, outcome for the events and insulin lispro treatment status was unknown.The mother of the patient was the operator of the humapen luxura burgundy devices and the humapen luxura half-dose device and her training status was not provided.The humapen luxura burgundy devices and the humapen luxura half-dose device general model duration of use were not provided.For both the humapen luxura burgundy device and the humapen luxura half-dose the device duration of use was not provided; however, but both suspect devices humapen luxura burgundy lot number 1206b01,1203b01 and humapen luxura half-dose device lot 1411g06 were started more than two years from the time of initial report.The suspect devices humapen luxura burgundy lot number 1206b01 (manufactured in jun2012), 1203b01 (manufactured in mar2012) and humapen luxura half-dose device lot 1411g06 (manufactured in nov2014), were returned to the manufacturer on 09dec2019.The reporting consumer did not provide an opinion of relatedness of events with insulin lispro treatment or the humapen luxura burgundy and humapen luxura half-dose devices.Update 02-dec-2019: information received on 25-nov-2019 and 26-nov-2019 were processed together.Update 10dec2019: additional information received on 09dec2019 from global product complaint database.Recoded the suspect humapen luxura hd (model ms9673) to a humapen luxura hd (model ms9673a).Updated the lot number from unknown to 1411g06 for product complaint (b)(6) relating to the humapen luxura hd device.Recoded humapen luxura, unknown pen body type to humapen luxura burgundy.Updated the lot number from unknown to 1206b01 for product complaint (b)(6) relating to the humapen luxura burgundy device.Corresponding fields and narrative updated accordingly.Edit 12-dec-2019: upon review of the case, operator of the device was updated to mother from other (unknown) and training status of the operator was added in the narrative.No other changes were made to the case.Edit 12dec2019: updated medwatch fields for expedited device reporting.No new information added.Update 12-dec-2019: additional information received on 09-dec-2019 via responsible complaint person (rcp).Suspect products were returned to the manufacturer.Suspect products insulin lispro cartridge with lot number d062140f, humapen luxura hd with lot number 1411g06 and humapen luxura with lot number 1206b01 were confirmed.A new humapen luxura lot number 1203b01 was also returned, reported and considered as suspect.A new suspect humapen luxura burgundy with batch number 1203b01 was added to the case.Pc (b)(4) was provided, processed and added to the narrative.Corresponding fields and narrative updated accordingly.Update 16jan2020: additional information received on 16jan2020 from the global product complaint database.Entered device specific safety summaries (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information, malfunction from unknown to no, and device return status to returned to manufacturer.Added date of manufacturer and date returned to manufacturer for the device for pc (b)(4) associated with lot 1203b01 of humapen luxura (burgundy), pc (b)(4) associated with lot 1206b01 of humapen luxura (burgundy), and pc (b)(4) associated with lot 1411g06 of humapen luxura hd.Corresponding fields and narrative updated accordingly.

• Brand Name: HP LUXURA, BURGUNDY
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• MDR Report Key: 9560288
• MDR Text Key: 189706920
• Report Number: 1819470-2019-00228
• 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: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9662
• Device Lot Number: 1203B01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/09/2019
• Date Manufacturer Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 18 YR