• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ELI LILLY AND COMPANY HUMAPEN LUXURA, BURGUNDY FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9662
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Stroke/CVA (1770); Hypoglycemia (1912)
Event Type  Injury  
Manufacturer Narrative
No further follow up is planned. Evaluation summary: the female patient reported the injection button of her humapen luxura device could not be pushed down. She experienced hypoglycemia. The device was not returned for investigation (batch (b)(4), manufactured august 2008). 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 pen jammed 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 with high probability. There is evidence of improper use. The patient reused needles. This may not be relevant to the event of hypoglycemia.
 
Event Description
Lilly case id: (b)(4). This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) year-old (b)(6) female patient. Medical history included historical drugs of metformin that cause constipation, acetylsalicylic acid cause stomach discomfort. Concomitant medication included acarbose, metformin and simvastatin, all for unspecified indication. The patient received insulin lispro protamine suspension 75%/ insulin lispro 25% (rdna origin) injection (humalog mix25) via reusable pen (humapen luxura) 30 (units not reported) twice daily subcutaneously for the treatment of diabetes mellitus, beginning in 2009. She also received human insulin isophane suspension 70%/ human insulin 30% (rdna origin) injections (humulin 70/30) via reusable pen (humapen luxura) 15 (units not reported) twice daily subcutaneously for the treatment of diabetes mellitus, beginning in 2009. In 2016, she did not have an adequate administration of unspecified insulin due to humapen luxura breakdown further described as the injection button could not be pushed down (lot number 0808b07/pc 4019987). She stated there was no foreign material in the pen. In addition, it was noted that the patient changed needles every tow to three days. On an unspecified date, she had a small stroke which was caused by hypoglycemia (values or units not reported). Stroke was considered serious due to medical significance. Information regarding corrective treatment and outcome of the event was not reported. Insulin lispro protamine suspension 75%/ insulin lispro 25% and human insulin isophane suspension 70%/ human insulin 30% treatment were continued. No follow-up would be requested since the reporter refused to provide more information. Treating physician contact details not provided. The operator of the humapen luxura and his/her training status was not provided. The duration of use for the device model was approximately eight years. The suspect device was reusable. The humapen luxura manufactured date was aug 2008. The humapen luxura was not returned to the manufacturer. The reporting consumer did not know if the events were related to insulin lispro protamine suspension 75%/ insulin lispro 25% or human insulin isophane suspension 70%/ human insulin 30% treatment and did not provide an assessment of relatedness between the events and humapen luxura. Edit 26-jun-2017: upon internal review it was upgraded hypoglycemia event to serious with criteria of medical significance. Updated fill causality of device from not associated to device nhcp, eu/ca fields and narrative accordingly. Update 28-jun-2017: additional information received from the initial reporter via a psp on 22-jun-2017. Reporter was inconvenient to accept follow-up thus case is considered lost to fu. Edit 29jun2017 case was opened to enter medwatch device fields and updated the (b)(4) device information, for device reporting. Update 06jul2017: additional information received on 06jul2017 from the global product complaint database. Recoded device from unknown to humapen luxura burgundy, entered device specific safety summary (dsss), updated medwatch fields and the (b)(4) device information, and improper use and storage from no to yes, all for the device associated with (b)(4). Added date of manufacturer. Corresponding fields and narrative updated accordingly.
 
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 (psp), concerned a (b)(6) female patient. Medical history included historical drugs of metformin that cause constipation, acetylsalicylic acid cause stomach discomfort. Concomitant medication included acarbose, metformin and simvastatin, all for unspecified indication. The patient received insulin lispro protamine suspension 75%/ insulin lispro 25% (rdna origin) injection (humalog mix25) via reusable pen (humapen luxura) 30 (units not reported) twice daily subcutaneously for the treatment of diabetes mellitus, beginning in 2009. She also received human insulin isophane suspension 70%/ human insulin 30% (rdna origin) injections (humulin 70/30) via reusable pen (humapen luxura) (lot 0808b07/(b)(4)) 15 (units not reported) twice daily subcutaneously for the treatment of diabetes mellitus, beginning in 2009. In 2016, she did not have an adequate administration of unspecified insulin due to humapen luxura breakdown. On an unspecified date, she had a small stroke which was caused by hypoglycemia (values or units not reported). Stroke was considered serious due to medical significance. Information regarding corrective treatment and outcome of the event was not reported. Insulin lispro protamine suspension 75%/ insulin lispro 25% and human insulin isophane suspension 70%/ human insulin 30% treatment were continued. No follow-up would be requested since the reporter refused to provide more information. Treating physician contact details not provided. The operator of the humapen luxura and his/her training status was not provided. The humapen luxura duration was not provided; she started using the humapen luxura in 2009. The reported humapen luxura duration of use was not reported. The action taken with the humapen luxura was not provided and its return was not expected. The reporting consumer did not know if the events were related to insulin lispro protamine suspension 75%/ insulin lispro 25% or human insulin isophane suspension 70%/ human insulin 30% treatment and did not provide an assessment of relatedness between the events and humapen luxura. Edit 26-jun-2017: upon internal review it was upgraded hypoglycemia event to serious with criteria of medical significance. Updated fill causality of device from not associated to device nhcp, eu/ca fields and narrative accordingly. Update 28-jun-2017: additional information received from the initial reporter via a psp on 22-jun-2017. Reporter was inconvenient to accept follow-up thus case is considered lost to fu. Edit 29jun2017 case was opened to enter medwatch device fields and updated the european and canadian (eu/ca) device information, for device reporting.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key6689227
MDR Text Key206923189
Report Number1819470-2017-00119
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 consumer,foreign,study
Type of Report Initial,Followup
Report Date 08/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMS9662
Device Lot Number0808B07
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/31/2008
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: 07/06/2017 Patient Sequence Number: 1
Treatment
ACARBOSE; HUMULIN 30% REGULAR, 70% NPH; INSULIN LISPRO (LISPRO 25% LISPRO 75% NPL); METFORMIN; SIMVASTATIN
-
-