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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Loss of consciousness (2418); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Narrative field; new updated and corrected information is referenced within the update statements in describe event or problem. No further follow up is planned. Evaluation summary: a female patient reported that she experienced abnormal blood glucose levels when using her humapen luxura device. The device was not returned for investigation (batch number unknown). Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction. Malfunction unknown. All humapen luxura devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring pen functionality with high probability. The patient reported that she is blind. The user manual states that the device is not recommended for the visually impaired without the assistance of a sighted individual trained to use it. There is evidence of improper use. The patient used the device while visually impaired. This may be relevant to the event of abnormal blood glucose levels.
 
Event Description
(b)(4). This spontaneous case, reported by a consumer who contacted the company to report an adverse event, concerned a female patient of unknown age and ethnicity. Medical history included vision aggravated on 1965, polyneuropathy with numbness of hands, since 1992 she did not produce insulin. On 1995 she experienced nerve breakdown and since 2003 she was blind also diabetic foot, osteoporosis and user insulin since 1965. Concomitant medications included moclobemide, vitamin b and ginkgo biloba for unknown indication. The patient received insulin lispro (rdna origin) (humalog) via cartridge and human insulin isophane suspension (rdna origin) (huminsulin nph) via cartridge 9iu, subcutaneously for the treatment of type 1 diabetes mellitus beginning on 1989. On 2015 she began to applied insulin lispro and human insulin isophane suspension with humapen (hp) luxura, burgundy. The patient reported that her humapen luxura burgundy was defective and had fallen apart ((b)(4) / lot number unknown). On an unknown date she experience blood glucose abnormal and fainted 4 hrs after applied glucagon as corrective treatment so she was fully recovered. Outcome of remain events was not provided. Status of insulin lispro and human insulin isophane suspension was not provided. The patient was the operator of the hp luxura and the training status was not provided. The duration of use for this device model was not provided. The suspect hp luxura duration of use was 2 years. The humapen luxura burgundy was not returned to the manufacturer. The reporting consumer did not provided an assessment of relatedness between the events and insulin lispro, insulin lispro isophane suspension treatment and hp luxura. Update 10mayapr2017: updated medwatch fields. Edit 16-may-2017: pc was received and processed accordingly. Device changes from unknown body to burgundy. Update 01jun2017: additional information received on 30may2017 from the global product complaint database. Entered device specific safety summary (dsss). Updated the medwatch fields with device information and the european and canadian (eu/ca) device information. Corresponding fields and narrative updated accordingly.
 
Manufacturer Narrative
There was no reported complaint for this device and its return is not expected. 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 an adverse event, concerned a female patient of unknown age and ethnicity. Medical history included vision aggravated on 1965, polyneuropathy with numbness of hands, since 1992 she did not produce insulin. On 1995 she experienced nerve breakdown and since 2003 she was blind also diabetic foot, osteoporosis and user insulin since 1965. Concomitant medications included moclobemide, vitamin b and ginkgo biloba for unknown indication. The patient received insulin lispro (rdna origin) (humalog) via cartridge and human insulin isophane suspension (rdna origin) (huminsulin nph) via cartridge 9iu, subcutaneously for the treatment of type 1 diabetes mellitus beginning on 1989. On 2015 she began to applied insulin lispro and human insulin isophane suspension with hp luxura. On an unknown date she experience blood glucose abnormal and fainted 4hrs after applied glucagon as corrective treatment so she was fully recovered. Outcome of remain events was not provided. Status of insulin lispro and human insulin isophane suspension was not provided. The patient was the operator of the hp luxura and the training status was not provided. The hp luxura model was not provided. The suspect hp luxura duration of use was 2 years. Action taken with hp luxura was not provided and returns was not expected. The reporting consumer did not provided an assessment of relatedness between the events and insulin lispro, insulin lispro isophane suspension treatment and hp luxura. Update 10may2017: updated medwatch fields.
 
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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 Key6560989
MDR Text Key113405432
Report Number1819470-2017-00080
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 06/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMS9662
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/30/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 05/11/2017 Patient Sequence Number: 1
Treatment
AURORIX; HUMINSULIN NPH; ROEKAN; VITAMIN B
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