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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 Break (1069); Crack (1135)
Patient Problems Infarction, Cerebral (1771); Hyperglycemia (1905); Hypoglycemia (1912); Dizziness (2194); Discomfort (2330); Ambulation Difficulties (2544)
Event Type  Injury  
Manufacturer Narrative
Narrative field: new, updated and corrected information is referenced within the update statements. Please refer to update statement(s) dated 03jun2020. No further follow-up is planned. This report is associated with (b)(4) since there is more than one device implicated. Evaluation summary: a male patient reported that his humapen luxura hd was not working. He experienced increased 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 also states if any of the parts of your humapen luxura hd appear broken or damaged, do not use, and to always carry a spare insulin pen in case your pen is lost or damaged. The patient reported he had poor eyesight. The core instructions for use state that the device is not recommended for the blind or the visually impaired without the assistance of a sighted individual trained to use the device. There is evidence of improper use. The patient used the device while visually impaired. It is unknown if this is relevant to the event of increased blood glucose.
 
Event Description
Lilly case id: (b)(4). This report is associated with product complaint: (b)(4). This solicited case reported by a consumer via patient support program (psp) concerned a (b)(6)-years-old asian male patient. Medical history included poor eyesight, renal problem, brain problem, heart disease/ischemia myocardial, bad eyes, various complication of diabetes and cerebral infarction since 2018 and his mother and elder brother had diabetes mellitus. Concomitant medications included metformin, glibenclamide and xiaoke (as reported); all used for type two diabetes mellitus. The patient received insulin lispro protamine suspension 75%/ insulin lispro 25% (rdna origin) injection (humalog 25, 100u/ml) from a cartridge via a reusable pen humapen ergo ii, 25 units each morning and 25 units each night, subcutaneously for the treatment of type two diabetes mellitus, beginning approximately on an unknown date in 2017. It was noted that the humapen ergo ii was dropped and broke (the pen cap was dropped and was cracked) due to poor eyesight (not further information was specified and it was considered as a improper use) (product complaint (b)(4), lot number unknown). On an unknown date, while on the insulin lispro protamine suspension 75%/insulin lispro 25% therapy, he had diabetic complications. Also, his blood glucose fluctuated greatly and was not well controlled (sometimes high and sometimes was low). On an unknown date, while on the insulin lispro protamine suspension 75%/insulin lispro 25% therapy, he was hospitalized for heart disease/ischemia myocardial and cerebral infarction. The cause of heart disease and cerebral infarction was that the blood glucose level was not well controlled (sometimes was high and sometimes was low). Also, he felt dizzy and walking unsteadily due to cerebral infarction and heart disease/ischemia myocardial. On an unspecified date, due to cerebral insufficiency and high blood glucose (no reference range was provided), he was hospitalized. On an unknown date, his eye condition did not change much after using insulin treatment. On an unknown date, he had fundus hemorrhage surgery and cataract surgery. The event of fundus hemorrhage was considered as serious due to its medical significance. As on (b)(6) 2020, he used insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injection (humalog 25, 100u/ml) from a cartridge via a reusable pen humapen luxura half-dose (hd). On an unknown date, the humapen luxura hd did not work (pc number: (b)(4); batch/lot number: unknown). On an unknown date, his blood glucose was little high (no unit, value or reference range was provided) and his body was uncomfortable. Information regarding further hospitalization details was not provided. As of (b)(6) 2020, he was not recovered from the events of discomfort and non serious episode of blood glucose increased. On an unknown date, he experienced poor control of blood glucose and high blood glucose (no values were provided). The fasting blood glucose during breakfast was 10-11 (no units were provided). In (b)(6) 2020, he was hospitalised due to high blood glucose. No more details regarding admission and discharge dates as well as treatment and laboratory tests done while hospitalized were provided. Information regarding further corrective treatment and outcome of the remaining events was not provided. Therapy with insulin lispro protamine suspension 75%/insulin lispro 25% was continued. The operator of the humapen ergo ii was the patient and his training status was not provided. The general humapen ergo ii model duration of use was not provided. The suspect device duration of use was noted to be one year ago. The use of the humapen ergo ii was ongoing. The suspect humapen ergo ii associated with product complaint (b)(4) was not returned to the manufacturer. The operator of the humapen luxura hd was the patient and his training status was not provided. The general humapen luxura hd model duration of use and suspect device duration of use were not provided. The suspect humapen luxura hd was associated with product complaint (b)(4) and the suspect luxura hd device was not returned. The initial reporting consumer did not related the events of discomfort and non serious episode of blood glucose increased with insulin lispro protamine suspension 75%/insulin lispro 25% therapy whereas related them with diet and irregular sports. The initial reporting consumer did not provide an assessment of relatedness between the remaining events and insulin lispro protamine suspension 75%/insulin lispro 25% therapy. The initial reporting consumer did not provide an assessment of relatedness between the all the events and humapen ergo ii. The initial reporting consumer did not provide an assessment of relatedness between the all the events and humapen luxura hd. This case was cross referenced with case (b)(4) (same patient). Update 28-dec-2018: information was received from the affiliate on 27-dec-2018 from affiliate via psp. Pc number was received. No medically significant information was added to the case. Update 11-jan-2019: additional information was received from the initial reporter on 10-jan-2019 via the psp. Added a medical history of cerebral infarction, onset date of medical history heart disease and two non-serious events of felt dizzy and walking unsteadily. Updated verbiage of medical history from heart disease to heart disease/ischemia and its coding from heart disorder to ischemia myocardial, verbiage of the event heart disease to possible heart disease/ischemia myocardial worsening and its coding from heart disorder to ischemia myocardial, verbiage of the event cerebral infarction to possible cerebral infarction worsening, verbiage of the event blood glucose level not well controlled (sometimes high and sometimes was low) to blood glucose level not well controlled/blood glucose fluctuated greatly (sometimes high and sometimes was low) and narrative with new information. Update 16-jul-2019: additional information was received from the initial reporter on 10-jul-2019 via the psp. Added: medical history: renal problem, brain problem; lab test of blood glucose and serious events: high blood glucose and cerebral insufficiency. Updated the therapy start date and dose of suspect drug. Updated the narrative with new information. Edit 23jul2019: updated medwatch fields for expedited device reporting. No new information added. Update 30jul2019: additional information received on 26jul2019 from the global product complaint database. Entered device specific safety summary (dsss). Updated the medwatch fields with device information, the european and (b)(6)(eu/(b)(6)) device information, and improper use and storage from no to yes for the suspect humapen ergo ii device associated with product complaint (b)(4), which was not returned to the manufacturer. Corresponding fields and narrative updated accordingly. Upon review, suspect device age was updated within the narrative from unknown to one year. Update 30jul2019: upon review, case priority was updated accordingly. Update 06aug2019: additional information received on 06aug2019 from the global product complaint database. No new information was added. Edit 06-aug-2019: upon internal review of information received on 06aug2019 from the global product complaint database, updated the date last updated field for the dsss for the suspect device accordingly. Update 20-aug-2019: additional information was received from the initial reporter via the psp on 16-aug-2019. Added medical history of poor eyesight, one serious event of fundus hemorrhage and one non-serious event of cataract. Updated narrative with new information. Update 05-mar-2020: additional information was received from the initial reporter on 28-feb-2020 via the psp. Added two medical histories of eye disorder and diabetic complication, and two non-serious events of blood glucose increased and discomfort. Added laboratory value of non serious event of blood glucose increased. Updated the case and narrative with new information. Update 11-mar-2020: additional information was received from the affiliate on 05-mar-2020 via the psp. Added a new suspect device of humapen luxura hd and associated the event of non-serious blood glucose increased (received on 28-feb-2020). Updated the narrative and causality statement. Update 18-mar-2020: correction of information received on 28-feb-2020 was received. Corrected information has already been updated in the case. No further information has been obtained. Update 19mar2020: additional information received on 12mar2020 from global product complaint database. Recoded the suspect humapen luxura half-dose device (model number ms9673) to suspect humapen luxura half-dose device (model number ms9673a). Reiterated the lot number unknown for product complaint (b)(4) relating to the humapen luxura half-dose device. Corresponding fields and narrative updated accordingly. Update 19-may-2020: additional information was received from initial reporter via psp on 14-may-2020. Added one serious event of blood glucose increased and its laboratory data. The humapen luxura hd was updated with eu/(b)(6) field. Updated the narrative with new information. Update 03jun2020: additional information received on 03jun2020 from the global product complaint database. Entered device specific safety summary (dsss). Updated the medwatch fields/ european and (b)(6) (eu/(b)(6)) device information, improper use and storage from no to yes, and device return status to not returned to manufacturer for (b)(4) associated with an unknown lot of a humapen luxura hd pen. Upon internal review, updated device use to patient. Corresponding fields and narrative updated accordingly. Update 05jun2020: additional information received on 05jun2020 from the global product complaint database. No new information was added.
 
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Brand NameHUMAPEN LUXURA HALF-DOSE PEN
Type of DeviceFOR 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
chris davis
lilly corporate center
indianapolis, IN 46285
3174334585
MDR Report Key10134305
MDR Text Key200983395
Report Number1819470-2020-00057
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K100988
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial
Report Date 06/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberMS9673A
Device Catalogue NumberMS9673
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/09/2020 Patient Sequence Number: 1
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