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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HP LUXURA, BURGUNDY; FOR TREATMENT PURPOSES
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ELI LILLY AND COMPANY HP LUXURA, BURGUNDY; FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9662
Device Problem Positioning Problem (3009)
Patient Problems Complaint, Ill-Defined (2331); Missed Dose (2561)
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 1819470-2019-00159 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 a (b)(6) year-old male patient of (b)(6) nationality.Medical history included cerebral infarction and dementia and family history included diabetes mellitus of hereditary diseases.Previous drug adverse reaction and family drug reaction were none.Concomitant medication included unspecified long-acting insulin for unknown indication.The patient received insulin lispro (rdna origin) injections (humalog, 100 u/ml) from a cartridge via reusable devices humapen unknown pen body type and humapen luxura, burgundy (purplish red, metal material), 18 units in the morning, 20 units in noon and 20 units at night three times a day subcutaneously, for the treatment of diabetes mellitus beginning approximately in 2014 or 2015.On an unknown date, while on insulin lispro treatment he was hospitalized every year for recuperating blood glucose.On an unknown date, his humapen unknown pen body type malfunctioned (pc# (b)(4); lot#: unknown).On an unknown date, he again had blood glucose (specific condition, values, units and reference range were not provided) due to which he was hospitalized on (b)(6) 2019 for recuperating blood glucose and to adjust the blood glucose.During this hospitalization, on physician advice he discontinued insulin lispro as it was inconvenient from him to use since it was needed to be injected three times a day therefore he changed to insulin lispro protamine suspension 50% insulin lispro 50% (humalog mix 50) from an unknown formulation via a reusable devices humapen luxura, burgundy and humapen unknown pen body type, at an unknown dose at an unknown route of administration as it was only needed twice a day for the treatment of an unknown indication beginning sometime in (b)(6) 2019.On (b)(6) 2019.His humapen luxura, burgundy could not be dialed in the afternoon (pc# (b)(4); lot#: unknown) due to which he missed dosage of insulin lispro protamine suspension 50% insulin lispro 50%.Information regarding further hospitalization details, corrective treatment and outcome of the events was not provided.The status of insulin lispro protamine suspension 50% insulin lispro 50% therapy was not provided whereas it was unknown if he would re-start insulin lispro treatment or not.The operator of the humapen, unknown body type and humapen luxura, burgundy was unknown and his/her training status was not provided.The general model humapen, unknown body type duration and the suspect humapen, unknown body type pen duration of use were started around four to five years ago in 2014 or 2015.The general humapen luxura, burgundy device model duration of use and the suspect humapen luxura, burgundy device duration of use were not reported.The action taken with suspect humapen, unknown body type pen and suspect humapen luxura, burgundy was not provided and their return status was not reported.The reporting consumer did not know of relatedness assessment between the event of blood glucose abnormal and insulin lispro treatment.The reporting consumer did not know if the event of missed dose was related to insulin lispro protamine suspension 50% insulin lispro 50% and the event of blood glucose abnormal was not associated with insulin lispro protamine suspension 50% insulin lispro 50%.The reporting consumer related the event of missed dose to humapen luxura, burgundy devices whereas did not provide any opinion on relatedness assessment for the remaining event to humapen, unknown body type and humapen luxura, burgundy devices.Edit 26-aug-2019: on review updated the device causality to not associated for event missed dose for humapen, unknown body type device.Edit 11sep2019: 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 dated 17sep2019 in the b.5.Field.No further follow-up is planned.This report is associated with 1819470-2019-00159 since there is more than one device implicated.Evaluation summary: a male patient reported that his humapen luxura device could not be dialed on 15-aug-2019 and he missed his dosage of insulin.The patient experienced abnormal blood glucose in (b)(6) 2019.The device was not returned for investigation (batch unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.All humapen luxura devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality with high probability.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 a 78-year-old male patient of han nationality.Medical history included cerebral infarction and dementia and family history included diabetes mellitus of hereditary diseases.Previous drug adverse reaction and family drug reaction were none.Concomitant medication included unspecified long-acting insulin for unknown indication.The patient received insulin lispro (rdna origin) injections (humalog, 100 u/ml) from a cartridge via reusable devices humapen unknown pen body type and humapen luxura, burgundy (purplish red, metal material), 18 units in the morning, 20 units in noon and 20 units at night three times a day subcutaneously, for the treatment of diabetes mellitus beginning approximately in 2014 or 2015.On an unknown date, while on insulin lispro treatment he was hospitalized every year for recuperating blood glucose.On an unknown date, his humapen unknown pen body type malfunctioned ((b)(4)/lot: unknown).On an unknown date, he again had blood glucose (specific condition, values, units and reference range were not provided) due to which he was hospitalized on (b)(6) 2019 for recuperating blood glucose and to adjust the blood glucose.During this hospitalization, on physician advice he discontinued insulin lispro as it was inconvenient from him to use since it was needed to be injected three times a day therefore he changed to insulin lispro protamine suspension 50%/insulin lispro 50% (humalog mix 50) from an unknown formulation via a reusable devices humapen luxura, burgundy and humapen unknown pen body type, at an unknown dose at an unknown route of administration as it was only needed twice a day for the treatment of an unknown indication beginning sometime in (b)(6) 2019.On (b)(6) 2019, his humapen luxura, burgundy could not be dialed in the afternoon ((b)(4)/lot: unknown) due to which he missed dosage of insulin lispro protamine suspension 50%/insulin lispro 50%.Information regarding further hospitalization details, corrective treatment and outcome of the events was not provided.The status of insulin lispro protamine suspension 50%/insulin lispro 50% therapy was not provided whereas it was unknown if he would re-start insulin lispro treatment or not.The operator of the humapen, unknown body type and humapen luxura, burgundy was unknown and his/her training status was not provided.The general model humapen, unknown body type duration and the suspect humapen, unknown body type pen duration of use were started around four to five years ago in 2014 or 2015.The general humapen luxura, burgundy device model duration of use and the suspect humapen luxura, burgundy device duration of use were not reported.The suspect humapen, unknown body type device associated with (b)(4) was not returned to the manufacturer.The suspect humapen luxura, burgundy device associated with (b)(4) was not returned to the manufacturer.The reporting consumer did not know of relatedness assessment between the event of blood glucose abnormal and insulin lispro treatment.The reporting consumer did not know if the event of missed dose was related to insulin lispro protamine suspension 50%/insulin lispro 50% and the event of blood glucose abnormal was not associated with insulin lispro protamine suspension 50%/insulin lispro 50%.The reporting consumer related the event of missed dose to humapen luxura, burgundy device whereas did not provide any opinion on relatedness assessment for the remaining event to humapen, unknown body type and humapen luxura, burgundy devices.Edit 26-aug-2019: on review updated the device causality to not associated for event missed dose for humapen, unknown body type device.Edit 11sep2019: updated medwatch fields for expedited device reporting.No new information added.Update 17sep2019: additional information received on 17sep2019 from the global product complaint database.Entered device specific safety summaries (dsss).Updated the medwatch fields with device information and the european and canadian (eu/ca) device information for the suspect humapen, unknown body type associated with (b)(4) and the suspect humapen luxura, burgundy associated with (b)(4), which were not returned to the manufacturer.Corresponding fields and narrative updated accordingly.
 
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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 Key8993861
MDR Text Key162011152
Report Number1819470-2019-00158
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 10/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS9662
Was Device Available for Evaluation? No
Date Manufacturer Received09/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age78 YR
Patient Weight70
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