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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN LUXURA BURGUNDY; FOR TREATMENT PURPOSES
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ELI LILLY AND COMPANY HUMAPEN LUXURA BURGUNDY; FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9662
Device Problems Mechanical Jam (2983); No Flow (2991)
Patient Problems Hyperglycemia (1905); 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 solicited case, reported by a consumer via patient support program (psp), concerned a (b)(6) female patient of unknown origin.Medical history included asthma and thyroid.Concomitant medications included insulin glargine for diabetes, ipratropium bromide monohydrate/salbutamol sulfate and budesonide/formoterol fumarate for asthma and desmond (as reported for allergy).The patient received insulin lispro (rdna origin) injection (humalog) unknown formulation via a reusable device (humapen luxura, burgundy), three times daily with variable doses for the treatment of diabetes, beginning in 2009.Dose was not provided.Since an unknown date, her humapen luxura was malfunctioned and was getting jammed and could not be pressed.She was using the same needle tip for 3-4 times.On (b)(6) 2019, she did not administer insulin lispro due to pen malfunction further described as jamming and it could not be pressed and had increased blood glucose to 350 (units and reference range were not provided) (lot number: 1206b01, product complaint number: (b)(4)).On an unknown date, when she received insulin, her blood glucose decrease to 40.The event of blood glucose decreased was considered as serious due to its medical significance.On an unknown date, she got a new pen.Information regarding corrective treatment, outcome of the events was not provided.Treatment with insulin lispro was continued.Follow up was not possible as the consent to contact reporter was declined and contact details of physician was not provided.The patient was the operator of humapen luxura and her training status was not provided.The model duration and suspect duration of use for humapen luxura was five years as started in 2014.The status of humapen luxura was continued and information regarding its return was not provided.The initial reporting consumer did not provide an opinion of relatedness between the events and insulin lispro treatment.The initial reporting consumer related the event of missed dose with malfunction associated with humapen luxura and did not provide relatedness for remaining events with humapen luxura.Update 26aug2019: additional information received on 26aug2019 from global product complaint database.Changed the lot number from 1106b03 to 1206b01 for product complaint (b)(4) relating to the humapen luxura (burgundy) device.Corresponding fields and narrative updated accordingly.Update 28-aug-2019: information was received from rcp via a psp on 26-aug-2019.Information regarding updated lot number (from 1106b03 to 1206b01) was provided which was already entered in the case.No new medically significant information was received and hence no changes were made to the case.Edit 05sep2019: updated medwatch fields for expedited device reporting.No new information added.
 
Event Description
Lilly case id: (b)(4).This solicited case, reported by a consumer via patient support program (psp), concerned a 55-year-old female patient of unknown origin.Medical history included asthma and thyroid.Concomitant medications included insulin glargine for diabetes, levothyroxine sodium for thyroid (unspecified disorder), ipratropium bromide monohydrate/salbutamol sulfate and budesonide/formoterol fumarate for asthma and desmond (as reported for allergy).The patient received insulin lispro (rdna origin) injection (humalog) unknown formulation via a reusable device (humapen luxura, burgundy), three times daily with variable doses for the treatment of diabetes, beginning in 2009.Dose was not provided.Since an unknown date, her humapen luxura malfunctioned and was getting jammed and could not be pressed along with the piston not proceeding.It was staying at the same level.On (b)(6) 2019, she did not administer insulin lispro due to pen malfunction further described as jamming and it could not be pressed and had increased blood glucose to 350 (units and reference range were not provided) (lot number: 1206b01, product complaint number: (b)(4).On an unknown date, when she received insulin, her blood glucose decrease to 40.The event of blood glucose decreased was considered as serious due to its medical significance.On an unknown date, she got a new pen.Information regarding corrective treatment, outcome of the events was not provided.Treatment with insulin lispro was continued.Follow up was not possible as the consent to contact reporter was declined and contact details of physician was not provided.The patient was the operator of humapen luxura and her training status was not provided.The model duration and suspect duration of use for humapen luxura was five years as started in 2014.The suspect device, which was manufactured in jun2012, was returned to the manufacturer on 26aug2019.The initial reporting consumer did not provide an opinion of relatedness between the events and insulin lispro treatment.The initial reporting consumer related the event of missed dose with malfunction associated with humapen luxura and did not provide relatedness for remaining events with humapen luxura.Update 26aug2019: additional information received on 26aug2019 from global product complaint database.Changed the lot number from 1106b03 to 1206b01 for product complaint: (b)(4) relating to the humapen luxura (burgundy) device.Corresponding fields and narrative updated accordingly.Update 28-aug-2019: information was received from rcp via a psp on 26-aug-2019.Information regarding updated lot number (from 1106b03 to 1206b01) was provided which was already entered in the case.No new medically significant information was received and hence no changes were made to the case.Edit 05sep2019: updated medwatch fields for expedited device reporting.No new information added.Update 16oct2019: additional information received on 15oct2019 from the global product complaint database.Entered device specific safety summary (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 4844125 associated with lot: 1206b01 of humapen luxura (burgundy) device.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 16oct2019 in the b.5.Field.No further follow-up is planned.Evaluation summary: the female patient reported that her humapen luxura malfunctioned and was getting jammed and could not be pressed.On (b)(6) 2019, she did not administer insulin and experienced a non-serious event of increased blood glucose.On an unknown date, when she received insulin, she experienced a serious event of decreased blood glucose.Investigation of the returned device (batch: 1206b01, manufactured: june 2012) found the device functioned normally.No malfunction was identified.There was glass foreign material observed on the external housing of the device, but not inside of the device and this material did not impact the functionality of the device.The foreign material was introduced while in the field and not during the manufacturing of the device.The patient reported she used the same needle tip for 3-4 times.The core instructions for use states to use a new needle for each injection.There is evidence of improper use.The patient reused needles.Needle reuse may be relevant to the complaint of device jamming and the non-serious event of increased blood glucose.
 
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Brand Name
HUMAPEN LUXURA BURGUNDY
Type of Device
FOR TREATMENT PURPOSES
Manufacturer (Section D)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis IN 46285
MDR Report Key8982821
MDR Text Key157462092
Report Number1819470-2019-00156
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K142518
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 11/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberMS9662
Device Lot Number1206B01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/26/2019
Date Manufacturer Received10/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age55 YR
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