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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN LUXURA CHAMPAGNE FOR TREATMENT PURPOSES

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ELI LILLY AND COMPANY HUMAPEN LUXURA CHAMPAGNE FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9663
Device Problems Device Inoperable (1663); Failure to Deliver (2338)
Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Neuropathy (1983); Pain (1994); Skin Discoloration (2074); Depression (2361)
Event Date 02/29/2016
Event Type  Injury  
Manufacturer Narrative
Since the device is not being returned, evaluation for a malfunction is not possible. 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, concerns a caucasian male patient of unknown age and origin born on (b)(6) 2016. Medical history: multiple myeloma described as bone marrow cancer secondary to low platelets count, arrhythmia, ischemia, heart disease and kidneys working just 50%. The concomitant medications included tramadol hydrochloride, zolpidem tartrate, mirtazapine, insulin glargine, metoprolol succinate, trimetazidine hydrochloride, bumetanide, spironolactone, clopidogrel, gabapentin and unspecified medication called gabadalina. All for unknown indication. The patient received insulin lispro (humalog) cartridge, 30iu each morning, 30iu each afternoon, 30 iu each evening, subcutaneously, for treatment of type 2 diabetes mellitus, beginning in 2012. On unknown date, during treatment with insulin lispro via humapen luxura champagne, the patient experienced frequent episodes of hypoglycemia with blood glucose of 70mg/dl (normal range not provided) and hyperglycemia with blood glucose of 180mg/dl (normal range not provided). The patient did not receive corrective treatment for hypoglycemia and hyperglycemia neither recovered from them. In 2014, the patient was diagnosed with diabetic neuropathy and due to that he experienced too much pain. In (b)(6) 2015, the patient was diagnosed with skin cancer and underwent a surgery to remove the cancer also in (b)(6) 2015. Since that diagnosis was made, the patient had depression. The patient did not receive corrective treatment for diabetic neuropathy and depression, neither recovered from depression. Outcome from skin cancer and diabetic neuropathy was not provided. Also on unspecified date, the preexisting events of arrhythmia, ischemia and heart disease worsened and due to that, he was hospitalized in (b)(6) 2016 during six days. While hospitalized, the patient experienced hypoglycemic crisis, whose blood glucose value reached 37mg/dl, which was considered serious due to medically significant reason by the company. On (b)(6) 2016, the patient was hospitalized again until (b)(6) 2016 due to worsening of arrhythmia, ischemia and heart disease. As corrective treatment he received metoprolol succinate, trimetazidine hydrochloride, bumetanide, spironolactone, clopidogrel but did not recover from arrhythmia, ischemia and heart disease. On unknown date, the patient underwent creatinine, urea and urine volume 24 hour and they showed that his kidneys were working just 29%. He did not receive corrective treatment neither recovered from event. On unspecified date, the belly of patient became purple after injection so, he started injecting on arms. On (b)(6) 2016, the humapen luxura champagne stopped working and did not deliver insulin lispro, thus, the patient did not receive his dose that day (lot 1305b09 and product complaint number (b)(4)), also he was sick. Corrective treatment and outcome from purple at injection site and sickness was not provided. Treatment with insulin lispro was continued. The wife of patient operated the device and she was trained by the drugstore employee. This device model and the reported device had used since 2012. The return of device was not expected since it had been discarded. The reporting consumer did not provide an opinion of relatedness. This case is cross referenced to (b)(4). Update 03may2015: additional information received on 28apr2016 and 29apr2016 was processed within initial case. Update 04may2016: upon review, this case was opened to update the medwatch and european and (b)(6) required device reporting elements for regulatory reporting.
 
Manufacturer Narrative
Narrative field; new updated and corrected information is referenced within the update statements. Please refer to statement dated 18may2016. No further follow up is planned. Evaluation summary a consumer reported, on behalf of a patient, the patient's humapen luxura device stopped working and did not deliver insulin. The patient experienced hypoglycemia. The device was not returned for investigation (batch 1305b09, manufactured may 2013). Therefore, the device could not be evaluated to confirm the complaint or presence of a malfunction. Malfunction unknown. A complaint history review of for the batch did not identify any atypical trends with regard to device not working or dose accuracy. All humapen luxura devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy. There is no evidence of improper use or storage.
 
Event Description
(b)(4). This solicited case, reported by a consumer via patient support program, concerns a caucasian male patient of unknown age and origin born on (b)(6) 2016. Medical history: multiple myeloma described as bone marrow cancer secondary to low platelets count, arrhythmia, ischemia, heart disease and kidneys working just (b)(6). The concomitant medications included tramadol hydrochloride, zolpidem tartrate, mirtazapine, insulin glargine, metoprolol succinate, trimetazidine hydrochloride, bumetanide, spironolactone, clopidogrel, gabapentin and unspecified medication called gabadalina. All for unknown indication. The patient received insulin lispro (humalog) cartridge, 30 iu each morning, 30 iu each afternoon, 30 iu each evening, subcutaneously, for treatment of type 2 diabetes mellitus, beginning in 2012. On unknown date, during treatment with insulin lispro via humapen luxura champagne, the patient experienced frequent episodes of hypoglycemia with blood glucose of 70mg/dl (normal range not provided) and hyperglycemia with blood glucose of 180mg/dl (normal range not provided). The patient did not receive corrective treatment for hypoglycemia and hyperglycemia neither recovered from them. In 2014, the patient was diagnosed with diabetic neuropathy and due to that he experienced too much pain. In (b)(6) 2015, the patient was diagnosed with skin cancer and underwent a surgery to remove the cancer also in (b)(6) 2015. Since that diagnosis was made, the patient had depression. The patient did not receive corrective treatment for diabetic neuropathy and depression, neither recovered from depression. Outcome from skin cancer and diabetic neuropathy was not provided. Also on unspecified date, the preexisting events of arrhythmia, ischemia and heart disease worsened and due to that, he was hospitalized in (b)(6) 2016 during six days. While hospitalized, the patient experienced hypoglycemic crisis, whose blood glucose value reached 37mg/dl, which was considered serious due to medically significant reason by the company. On (b)(6) 2016, the patient was hospitalized again until (b)(6) 2016 due to worsening of arrhythmia, ischemia and heart disease. As corrective treatment he received metoprolol succinate, trimetazidine hydrochloride, bumetanide, spironolactone, clopidogrel but did not recover from arrhythmia, ischemia and heart disease. On unknown date, the patient underwent creatinine, urea and urine volume 24 hour and they showed that his kidneys were working just (b)(6). He did not receive corrective treatment neither recovered from event. On unspecified date, the belly of patient became purple after injection so, he started injecting on arms. On (b)(6) 2016, the humapen luxura champagne stopped working and did not deliver insulin lispro, thus, the patient did not receive his dose that day (lot 1305b09 and product complaint number (b)(4)), also he was sick. Corrective treatment and outcome from purple at injection site and sickness was not provided. Treatment with insulin lispro was continued. The wife of patient operated the device and she was trained by the (b)(4) employee. This device model and the reported device had used since 2012. The return of device was not expected since it had been discarded. The reporting consumer did not provide an opinion of relatedness. (b)(4).
 
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Brand NameHUMAPEN LUXURA CHAMPAGNE
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
caroline rosewell
lilly corporate center
indianapolis, IN 46285
3172764376
MDR Report Key5637661
MDR Text Key44700233
Report Number1819470-2016-00114
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 04/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMS9663
Device Lot Number1305B09
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/31/2013
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: 05/06/2016 Patient Sequence Number: 1
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