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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN LUXURA HALF-DOSE PEN; FOR TREATMENT PURPOSES
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ELI LILLY AND COMPANY HUMAPEN LUXURA HALF-DOSE PEN; FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9673A
Device Problems Improper or Incorrect Procedure or Method (2017); Inaccurate Delivery (2339); Mechanics Altered (2984)
Patient Problem Hypoglycemia (1912)
Event Date 03/19/2021
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
Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report an adverse event and product complaint (pc), concerned a (b)(6) female patient with unknown origin.Medical history included being type 1 diabetic.Concomitant medication included other manufacturer insulin glargine for the treatment of type 1 diabetes.The patient received insulin lispro (rdna origin) injections (humalog, 100u/ml), from cartridge via a reusable device humapen luxura hd, at unknown dose, on a 1:9 ratio with her carbohydrate ratio along with other manufacturer insulin glargine on a 1:8 ratio, subcutaneously, for the treatment of type 1 diabetes, beginning on an unknown date.She was using insulin lispro via a humapen luxura hd since 2016 which was improper use since the period of intended use for the humapen luxura hd was three years.Approximately on (b)(6) 2021 (first time), she had serious low of blood sugar and she took glucagon as corrective treatment.Since an unknown date, humapen luxura hd was not functioning properly.On an unknown date, she possibly did not get the correct dose because of the spinning mechanism (lot number: unknown, pc number: (b)(4)).On an unknown date, she was being tested for coeliac disease but the results were not available.Reportedly, through a lot of work her lows was prevented but she was not sleeping.She would go low in the middle of the night for no reason and then would have to wake up take carbs.She was taking insulin 10 minutes ahead of carbs but now she was taking insulin right when she was eating and it had helped but not solved it.The event of low sugar was reported as serious by the reporter.Outcome of the event multiple lows was not resolved.Information regarding corrective treatment of remaining event, outcome of remaining event and status of insulin lispro treatment was not provided.The patient was the operator of humapen luxura hd and her training status was not provided.The general humapen luxura hd duration was not provided and suspect humapen luxura hd duration was approximately five years as it was started in 2016.The status of humapen luxura hd and information regarding its return was unknown.The initial reporting consumer did not know if the event was related to insulin lispro treatment or humapen luxura hd.The initial reporting consumer did not provide relatedness of remaining event with insulin lispro treatment and related it with the product complaint/issue associated with humapen luxura hd.Edit 13may2021: updated medwatch and european and (b)(6) (eu/(b)(6)) fields for expedited device reporting.No new information added.Edit 20may2021: added unique identifier (udi) (b)(4); no new information added.
 
Event Description
Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report an adverse event and product complaint (pc), concerned a 20-year-old female patient with unknown origin.Medical history included being type 1 diabetic.Concomitant medication included other manufacturer insulin glargine for the treatment of type 1 diabetes.The patient received insulin lispro (rdna origin) injections (humalog, 100u/ml), from cartridge via a reusable device humapen luxura hd, at unknown dose, on a 1:9 ratio with her carbohydrate ratio along with other manufacturer insulin glargine on a 1:8 ratio, subcutaneously, for the treatment of type 1 diabetes, beginning on an unknown date.She was using insulin lispro via a humapen luxura hd since 2016 which was improper use since the period of intended use for the humapen luxura hd was three years.Approximately on (b)(6) 2021 (first time), she had serious low of blood sugar and she took glucagon as corrective treatment.Since an unknown date, humapen luxura hd was not functioning properly.On an unknown date, she possibly did not get the correct dose because of the spinning mechanism (lot number: unknown, pc number: (b)(4)).On an unknown date, she was being tested for coeliac disease but the results were not available.Reportedly, through a lot of work her lows was prevented but she was not sleeping.She would go low in the middle of the night for no reason and then would have to wake up take carbs.She was taking insulin 10 minutes ahead of carbs but now she was taking insulin right when she was eating and it had helped but not solved it.The event of low sugar was reported as serious by the reporter.Outcome of the event multiple lows was not resolved.Information regarding corrective treatment of remaining event, outcome of remaining event and status of insulin lispro treatment was not provided.The patient was the operator of humapen luxura hd and her training status was not provided.The general humapen luxura hd duration was not provided and suspect humapen luxura hd duration was approximately five years as it was started in 2016.The status of humapen luxura hd was unknown and was not returned to manufacturer.The initial reporting consumer did not know if the event was related to insulin lispro treatment or humapen luxura hd.The initial reporting consumer did not provide relatedness of remaining event with insulin lispro treatment and related it with the product complaint/issue associated with humapen luxura hd.Edit (b)(6) 2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit (b)(6) 2021: added unique identifier (udi) (b)(4); no new information added.Update (b)(6) 2021: additional information received on 09jun2021 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information and device return status to not returned to manufacturer for (b)(4) associated with unknown lot of humapen luxura hd device.Corresponding fields and narrative updated accordingly.Edit (b)(6) 2021: updated medwatch fields for expedited device reporting.No new information added.
 
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 10jun2021 in the b.5.Field.No further follow-up is planned.Evaluation summary: a female patient reported that she possibly did not get the correct dose when using her humapen luxura hd device because "the dial end was loose and spins very easily." the patient experienced decreased blood glucose.The device was not returned to the manufacturer for investigation (batch unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.All humapen luxura hd devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy with high probability.The core instructions for use states to always carry a spare insulin pen in case your pen is lost or damaged.The patient reportedly used the device for five years.The core instructions for use state the humapen luxura hd is designed to be used for up to three years after first use.There is evidence of improper use.The patient used the device beyond its approved use life.It is unknown if this misuse is relevant to the complaint or the event of decreased blood glucose.
 
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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
MDR Report Key11855338
MDR Text Key266370971
Report Number1819470-2021-00071
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00300029673019
UDI-Public00300029673019
Combination Product (y/n)N
PMA/PMN Number
K100988
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 06/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberMS9673A
Device Catalogue NumberMS9673
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received06/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age20 YR
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