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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 Improper or Incorrect Procedure or Method (2017)
Patient Problems Hyperglycemia (1905); Hypersensitivity/Allergic reaction (1907)
Event Date 08/31/2016
Event Type  Injury  
Manufacturer Narrative
If device is returned, evaluation will be performed to determine if a malfunction has occurred. This is an intial report. A report will be submitted when the final evaluation has been completed.
 
Event Description
(b)(4). This case is associated with product complaint (b)(4). This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) patient. Medical history included hypertension, coronary artery disease, myocardial infarction, cerebral infarction and an allergic reaction to an unspecified insulin on the injection site that looked like rubella. Concomitant medications included acarbose and repaglinide for unknown indications. The patient received insulin lispro protamine suspension 75%/ insulin lispro 25% (rdna origin) injections (humalog mix25 100 u/ml) through a cartridge via a humapen luxura, 20 iu twice daily subcutaneously for the treatment of diabetes mellitus beginning in 2010. On an unspecified date, after injecting insulin lispro protamine suspension 75%/ insulin lispro 25% he had an allergic reaction on the injection site. His physician suggested increasing his dose to one unit on an unspecified date. On an unspecified date in 2016 his blood glucose was high (no values reported) after meals so his physician changed him to insulin lispro protamine suspension 50%/ insulin lispro 50% (rdna origin) injections (humalog mix50 100 u/ml) through a cartridge via humapen luxura, 15 iu three times a day subcutaneously for the treatment of diabetes mellitus. Since an unspecified date he had leg pain symptoms and in (b)(6) 2016 he was hospitalized because of femoral head necrosis and piriformis syndrome. On an unspecified date in (b)(6) 2016 he was hospitalized because his blood glucose was high (no values reported). Further details including discharge date were not provided. After changing to insulin lispro protamine suspension 50%/ insulin lispro 50% his blood glucose was still high (no values reported). On (b)(6) 2016 his humapen luxura broke down and because of that he administered an incorrect amount of insulin lispro protamine suspension 50%/ insulin lispro 50%. Information regarding corrective treatment and outcome of the events was not reported. Insulin lispro protamine suspension 50%/ insulin lispro 50% treatment was continued. The patient was the operator of the humapen luxura and his training status was unknown. The general humapen luxura and suspect humapen luxura durations of use were of approximately six years. The humapen luxura was discontinued on (b)(6) 2016 and would be evaluated if returned. The reporting consumer did not know if the events were related to insulin lispro protamine suspension 75%/ insulin lispro 25% or insulin lispro protamine suspension 50%/ insulin lispro 50% or the humapen luxura. Edit 14oct2016. Case was opened to enter medwatch device fields and the to update the european/canadian device fields for device mailing. No new information. Update 19-oct-2016: information received on 17-oct-2016 from the affiliate. It was reported that the reporter hung up the phone thus follow-up information could not be pursued. No changes performed.
 
Manufacturer Narrative
New, updated and corrected information is referenced within the update statements in please refer to update statement dated (b)(6) 2016 in the field. No further follow up is planned. Evaluation summary a male patient reported the injection screw of his humapen luxura was loose, and it would not move the plunger of the insulin cartridge. The patient experienced increased blood glucose levels. The device was not returned to the manufacturer for investigation (batch (b)(4), manufactured may 2009). Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction. Malfunction unknown. A complaint history review for the batch did not identify any atypical findings with regard to dose accuracy or injection screw/ratchet not moving. All humapen luxura devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy with high probability. There is no evidence of improper use or storage.
 
Event Description
(b)(4). This solicited case, reported by a consumer via a patient support program (psp), with additional information from the initial reporter, concerned a (b)(6) male han patient. Medical history included hypertension, coronary artery disease, myocardial infarction, cerebral infarction,an allergic reaction to an unspecified insulin on the injection site that looked like rubella, necrosis of the left hip, left blood clots (specific site was unknown) also had history of alcohol abuse, coagulopathy, chronic liver disease, chronic unspecified corticosteroids user, gout and systemic lupus erythematosus. Concomitant medications included acarbose and repaglinide for unknown indications. The patient received insulin lispro protamine suspension 75%/ insulin lispro 25% (rdna origin) injections (humalog mix25 100 u/ml) through a cartridge via a humapen luxura burgundy, 20 iu twice daily subcutaneously for the treatment of diabetes mellitus beginning in 2010. On an unspecified date, after injecting insulin lispro protamine suspension 75%/ insulin lispro 25% he had an allergic reaction on the injection site. His physician suggested increasing his dose to one unit on an unspecified date. On an unspecified date in 2016 his blood glucose was high (no values reported) after meals so his physician changed him to insulin lispro protamine suspension 50%/ insulin lispro 50% (rdna origin) injections (humalog mix50 100 u/ml) through a cartridge via humapen luxura, 15 iu three times a day subcutaneously for the treatment of diabetes mellitus. Since an unspecified date he had leg pain symptoms and in (b)(6) 2016 he was hospitalized because of femoral head necrosis and piriformis syndrome; the cause of the piriformis syndromes was diabetes. On an unspecified date in (b)(6) 2016 he was hospitalized because his blood glucose was high (no values reported). Further details including discharge date were not provided. After changing to insulin lispro protamine suspension 50%/ insulin lispro 50% his blood glucose was still high (no values reported). On (b)(6) 2016 his humapen luxura broke down (pc (b)(4), lot 0905b05) lot and because of that he administered an incorrect amount of insulin lispro protamine suspension 50%/ insulin lispro 50%. Information regarding corrective treatment and outcome of the events was not reported. Insulin lispro protamine suspension 50%/ insulin lispro 50% treatment was continued. The patient was the operator of the humapen luxura and his training status was unknown. The general humapen luxura and suspect humapen luxura durations of use were of approximately six years. The humapen luxura was not returned. The reporting consumer did not know if the events were related to insulin lispro protamine suspension 75%/ insulin lispro 25% or insulin lispro protamine suspension 50%/ insulin lispro 50% or the humapen luxura but the cause of piriformis syndrome might be diabetes. Edit (b)(6) 2016. Case was opened to enter medwatch device fields to update the (b)(6) device fields for device mailing. No new information. Update (b)(6) 2016: information received on (b)(6) 2016 from the affiliate. It was reported that the reporter hung up the phone thus follow-up information could not be pursued. No changes performed. Update (b)(6) 2016: additional information was received from the initial reporter on (b)(6) 2016. Updated causality statement with new information. No more changes were made to this case. Update (b)(6) 2016: additional information received on (b)(6) 2016 from the global product complaint database added the device specific safety summary and manufactured date of the device; added the device was not returned; updated the device to a humapen luxura burgundy based on a verifiable lot number; updated the medwatch and (b)(6) required device reporting elements; and updated the narrative. Update 22-nov-2016: additional information received from the rcp on (b)(6) 2016. Product complaint (b)(4) was added to the narrative. No new adverse event information. Update 29-nov-2016: additional information was received from the initial reporter on (b)(6) 2016: added necrosis of the left hip, left blood clots (specific site was unknown) also had history of alcohol abuse, coagulopathy, chronic liver disease, chronic unspecified corticosteroids user, gout and systemic lupus erythematosus as medical history. Updated narrative with new information.
 
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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
caroline rosewell
lilly corporate center
indianapolis, IN 46285
3172764376
MDR Report Key6067636
MDR Text Key58817177
Report Number1819470-2016-00271
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 10/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMS9662
Device Lot Number0905B05
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/21/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/31/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/31/2016 Patient Sequence Number: 1
Treatment
GLUCOBAY; INSULIN LISPRO 25%; INSULIN LISPRO 50%; NOVONORM
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