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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 Problems Unintended Ejection (1234); Device Inoperable (1663); Difficult or Delayed Activation (2577)
Patient Problem Hyperglycemia (1905)
Event Date 05/22/2016
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 spontaneous case, reported by a consumer who contacted the company to report adverse events and a product complaint, concerned a chinese female patient of unknown age. Medical history and concomitant medication were not provided. The patient received insulin lispro protamine suspension 50%/ insulin lispro 50% (rdna origin) (humalog mix50) injections from a cartridge, via reusable pen (humapen luxura burgundy), 18 units in the morning and 6 units at night subcutaneously for the treatment of diabetes mellitus beginning approximately since (b)(6) 2015, the dosage regimen was not provided. On (b)(6) 2016, his fasting blood glucose (fbg) was 20 (no units provided) and his postprandial blood glucose (ppbg) two hours after meal increased and was from 24 to 25 (no units provided). On (b)(6) 2016, she was hospitalized due to her blood glucose was high. After hospitalization, physician let her to use other brand of insulin (no details were provided), and her blood glucose was decreased after changed the insulin (no values were provided). On (b)(6) 2016, physician changed to use insulin lispro protamine suspension 50%/ insulin lispro 50% again with dosage of 28 units in the morning and 22 units in the evening. After using insulin lispro protamine suspension 50%/ insulin lispro 50% at this dosage, her fbg was 14 (no units provided) and her ppbg two hours after meal was 17 (no units provided) so she was hospitalized again on unspecified date. The second blood glucose increased was caused due to humapen luxura injection failure, since insulin lispro protamine suspension 50%/ insulin lispro 50% could not be injected into her body approximately since (b)(6) 2016 when the injection button was hard to press ((b)(4)/lot 1211b01), and insulin could not be injected into body, but flew out from injection sites. By (b)(6) 2016, she was still in hospital. Information regarding corrective treatment, outcome for the remaining events, and insulin lispro protamine suspension 50%/ insulin lispro 50% treatment status after reintroduction was not provided. She was the humapen luxura operator, and her training status was not provided. The general device model duration of use was not provided but it started in (b)(6) 2015, and the suspect device duration of use was not reported. The status of the suspect device was not provided. The consumer reporter did not know if the events were causally related to insulin lispro protamine suspension 50%/ insulin lispro 50% treatment or to humapen luxura device. No follow-up would be requested since the reporter refused to provide more information. Treating physician contact details not provided. Edit 14-jun-2016: upon review, the listedness assessment was updated by including the ib, spc and uspi label. No other change was made. Edit 14-jun-2016: upon review the dose regimen of suspect drug was updated, updated suspect drug action taken, dechallenge and rechallenge results, the eu/ca fields were populated, and added a second blood glucose increased episode as a serious adverse event. Updated corresponding fields and narrative properly. Update 15-jun-2015: upon review, this case was opened to update the device to a humapen luxura burgundy based on a verifiable lot number; update the medwatch fields for regulatory reporter; and to add the product complaint number to the narrative. Update 22-jun-2016: additional information was received on 17-jun-2016. Consumer refused to be contacted anymore. Narrative was updated accordingly.
 
Manufacturer Narrative
Evaluation summary: the female patient reported that the injection button of her humapen luxura device was hard to press and insulin could not be injected into body, but flew out from injection sites. She experienced increased blood glucose levels. The device was not returned for investigation (batch 1211b01, manufactured november 2012). Therefore, it 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 leaking after injection from injection site, injection force high, 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 spontaneous case, reported by a consumer who contacted the company to report adverse events and a product complaint, concerned a (b)(6) female patient of unknown age. Medical history and concomitant medication were not provided. The patient received insulin lispro protamine suspension 50%/ insulin lispro 50% (rdna origin) (humalog mix50) injections from a cartridge, via reusable pen (humapen luxura burgundy), 18 units in the morning and 6 units at night subcutaneously for the treatment of diabetes mellitus beginning approximately since (b)(6) 2015, the dosage regimen was not provided. On (b)(6) 2016, his fasting blood glucose (fbg) was 20 (no units provided) and his postprandial blood glucose (ppbg) two hours after meal increased and was from 24 to 25 (no units provided). On (b)(6) 2016, she was hospitalized due to her blood glucose was high. After hospitalization, physician let her to use other brand of insulin (no details were provided), and her blood glucose was decreased after changed the insulin (no values were provided). On (b)(6) 2016, physician changed to use insulin lispro protamine suspension 50%/ insulin lispro 50% again with dosage of 28 units in the morning and 22 units in the evening. After using insulin lispro protamine suspension 50%/ insulin lispro 50% at this dosage, her fbg was 14 (no units provided) and her ppbg two hours after meal was 17 (no units provided) so she was hospitalized again on unspecified date. The second blood glucose increased was caused due to humapen luxura injection failure, since insulin lispro protamine suspension 50%/ insulin lispro 50% could not be injected into her body approximately since (b)(6) 2016 when the injection button was hard to press (product complaint (b)(4)/lot 1211b01), and insulin could not be injected into body, but flew out from injection sites. By (b)(6) 2016, she was still in hospital. Information regarding corrective treatment, outcome for the remaining events, and insulin lispro protamine suspension 50%/ insulin lispro 50% treatment status after reintroduction was not provided. She was the humapen luxura operator, and her training status was not provided. The general device model duration of use was not provided but it started in (b)(6) 2015, and the suspect device duration of use was not reported. The status of the suspect device was not provided. The consumer reporter did not know if the events were causally related to insulin lispro protamine suspension 50%/ insulin lispro 50% treatment or to humapen luxura device. No follow-up would be requested since the reporter refused to provide more information. Treating physician contact details not provided. Edit 14-jun-2016: upon review, the listedness assessment was updated by including the ib, spc and uspi label. No other change was made. Edit 14-jun-2016: upon review the dose regimen of suspect drug was updated, updated suspect drug action taken, dechallenge and rechallenge results, the eu/ca fields were populated, and added a second blood glucose increased episode as a serious adverse event. Updated corresponding fields and narrative properly. Update 15-jun-2015: upon review, this case was opened to update the device to a humapen luxura burgundy based on a verifiable lot number; update the medwatch fields for regulatory reporter; and to add the product complaint number to the narrative. Update 22-jun-2016: additional information was received on 17-jun-2016. Consumer refused to be contacted anymore. Narrative was updated accordingly. Update 29jun2016. Additional information received 28jun2016 from the product complaint safety database. To the device tab added the device specific safety summary (dsss), updated the european and canadian (eu/ca) device information, updated the device medwatch information, added the manufacture date, and the narrative was updated accordingly. Edit 29jun2016. Corrected medwatch entry.
 
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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 Key5748146
MDR Text Key48122076
Report Number1819470-2016-00146
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
Type of Report Initial,Followup
Report Date 06/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMS9662
Device Lot Number1211B01
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/28/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/30/2012
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: 06/24/2016 Patient Sequence Number: 1
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