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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 Problem Insufficient Information (3190)
Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Retinal Injury (2048)
Event Date 03/31/2014
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 a patient support program, concerned a (b)(6) female. Medical history included high blood pressure, coronary heart disease, hypertension and penicillin allergy. Concomitant medications included acarbose for unknown indications. The patient received insulin lispro protamine suspension 50%/ insulin lispro 50% (humalog mix50), via a cartridge subcutaneously using reusable humapen luxura burgundy device at 06 units each morning, 4 units at noon, and 08 units each evening for the treatment of diabetes mellitus beginning in 2010. Also reported that she was taking 08 units each morning, 04 units at noon, and 06 units each evening in 2012. On an unknown date in 2013, she experienced ocular fundus hemorrhage caused by a cold and was hospitalized. She changed insulin lispro protamine suspension 50%/ insulin lispro 50% to insulin lispro protamine suspension 75%/ insulin lispro 25% at 04 units in morning, 04 units at noon and 06 units at night, after medical advice when she was hospitalized. In (b)(6) 2014, she experienced high fasting blood glucose/hyperglycemia of 12 to 14 (units not provided) and was hospitalized. Corrective treatment included addition of acarbose and the event outcome was recovering. On an unknown date in (b)(6) 2014, during hospitalization for hyperglycemia, the physician discontinued insulin lispro protamine suspension 50%/ insulin lispro 50% and started insulin lispro protamine suspension 75%/ insulin lispro 25% (humalog mix25) at 8 units morning, 4 units noon and 6 units night (conflicting information reporter regarding discontinuation of insulin lispro protamine suspension 50%/ insulin lispro 50%). Since (b)(6) 2014, she experienced hypoglycemia after each use of insulin lispro protamine suspension 75%/ insulin lispro 25%. No blood glucose values were provided and the event was recovering after treatment with oral carbohydrates. On (b)(6) 2015, time to onset of 13 months, she did not inject insulin due to injection pen problem (lot 1105b06/(b)(4)) and fasting blood glucose was high at 12 to 14 (postprandial were not measured). On (b)(6) 2015 follow-up, recent blood glucose levels were still high with reported fasting blood-glucose of 11. 79, 12 and postprandial blood glucose of 10 (units not provided). On (b)(6) 2015, her insulin lispro protamine suspension 75%/ insulin lispro 25% dose was changed to 6 units morning, 4 units noon and 6 units night and after the dose change she had not experienced hypoglycemia since then. On (b)(6) 2018, her hand was broken because the road covered with snow was slippery and arms were broken. On (b)(6) 2018, she did not inject enough insulin because there was no insulin in the injection pen. Event outcome of hospitalized due to high fasting blood glucose/hyperglycemia was recovering, outcome of fasting blood glucose slightly higher was not recovering and the outcome of hypoglycemia was recovering. The outcome of remaining events was not reported. Insulin lispro protamine suspension 75%/ insulin lispro 25% was continued and insulin lispro protamine suspension 50%/ insulin lispro 50% was discontinued. The operator of humapen luxura burgundy was patient and her training status was not reported. The general and suspect humapen luxura burgundy duration of use was two years. The action taken with humapen luxura burgundy was not reported. The humapen luxura burgundy device was not returned. The consumer reporter related blood glucose increased (serious) and blood glucose decreased as related to insulin lispro protamine suspension 50%/ insulin lispro 50%. The reporting consumer did not know the relatedness between cold, ocular fundus hemorrhage and insulin lispro protamine suspension 50%/ insulin lispro 50%. The remaining events were not associated with insulin lispro protamine suspension 50%/ insulin lispro 50%. The related blood glucose increased (non-serious) and blood glucose decreased as related to insulin lispro protamine suspension 75%/ insulin lispro 25%. The reporting consumer did not know relatedness between cold, ocular fundus hemorrhage, hand fracture, incorrect dose administered and insulin lispro protamine suspension 75%/ insulin lispro 25%. The remaining events were not associated with insulin lispro protamine suspension 75%/ insulin lispro 25%. Update 13may2015: additional information was received 11may2015 from the consumer reporter. On 12may2015, (b)(4) was provided. Added lab data, updated outcome of blood glucose to not recovered, updated causality, and updated causality statement. Narrative updated with new information. Update 29may2015: additional information received on 29may2015 from the global product complaint database added the device specific safety summary and manufactured date of the device; updated the device to a humapen luxura burgundy based on the verified lot number; added the device was not returned; updated the eu/ca fields; and updated the narrative. Update 13jul2015: additional information was received on 09jul2015 from a consumer via a patient support program. Added patients date of birth, medical history, added fasting blood glucose value of 11. 79 and updated event outcomes and causality. Updated narrative with the new information. Update 15jul2015: upon review, this case was opened to update the medwatch fields for regulatory reporting. Update 24-jan-2018: additional information was received on 18-jan-2018 from initial consumer via a patient support program. Updated formulation of insulin lispro protamine suspension 75%/ insulin lispro 25% and insulin lispro protamine suspension 50%/ insulin lispro 50%. Added two medical histories, three dosage regimen for insulin lispro protamine suspension 75%/ insulin lispro 25% and insulin lispro protamine suspension 50%/ insulin lispro 50%, serious events of cold and ocular fundus hemorrhage, non-serious events of hand fracture and incorrect dose administered. Updated narrative with the new information. Edit 09-feb-2018: upon review of cire report upon receipt of product complaint number, added missing event of arm fracture and suspect device humapen luxura burgundy. Pc was processed accordingly. Update 15feb2018: updated medwatch fields for expedited device reporting. No new information added. Edit 16-feb-2018: upon review of reporter received on 18-jan-2018 and cire report, added missing listedness for event of arm fracture and corrected eu/ca fields for suspect device humapen luxura burgundy.
 
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Brand NameHUMAPEN LUXURA BURGUNDY
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 Key7277656
MDR Text Key100312003
Report Number1819470-2018-00019
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 03/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMS9662
Device Lot Number1105B06
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/21/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/31/2011
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: 02/16/2018 Patient Sequence Number: 1
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