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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN LUXURA HALF-DOSE PEN FOR TREATMENT PURPOSES

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ELI LILLY AND COMPANY HUMAPEN LUXURA HALF-DOSE PEN FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9673
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Eye Injury (1845); Hyperglycemia (1905); Urinary Tract Infection (2120); Visual Disturbances (2140)
Event Type  Injury  
Manufacturer Narrative
New updated and corrected information is referenced within the update statements. Please refer to statement dated 19oct2017. No further follow up is planned. Evaluation summary: a female patient reported an unspecified problem with the plunger of her humapen luxura hd. The patient experienced increased blood glucose. The device was not returned for investigation (batch unknown). Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction. Malfunction unknown. All humapen luxura hd devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy with high probability. Troubleshooting was performed by the patient with guidance from a trained professional, including instruction on priming the device. After troubleshooting, the device functioned normally. The patient stated that when her glucose increased, her eye vessels were bursting. The instructions for use state the humapen luxura hd is not recommended for the blind or visually impaired without the assistance of a sighted individual trained to use it. " there is evidence of improper use. The patient used the device and was visually impaired. It is unknown if this is relevant to the event of increased blood glucose.
 
Event Description
Lilly case id: (b)(4). Product complaint: (b)(4). This spontaneous case, reported by a consumer, who contacted the company to report a product complaint and an adverse event, concerns a female patient of unknown age and ethnicity. Medical history and concomitant medications were not provided. The patient received human insulin (rdna origin) regular (humulin r) cartridge and human insulin (rdna origin) nph (humulin n) unknown formulation, both of unknown dose, route, frequency, indication and start date. It was unknown how human insulin nph was delivered. Since (b)(6) 2017, the patient received human insulin regular via humapen luxura half-dose (lot unknown). Since unspecified date, unknown time after beginning treatment with human insulin regular via humapen luxura half-dose and human insulin nph, every time patients glucose increased her eye vessels were bursting (as reported). The event of eye vessels that were bursting were considered serious due to medically significant reason by the company. Laboratorial exams were not provided. Patient s physician stated that nothing could be done regarding the eye vessels and what had been damaged had no way of fixing, but patient should control her glycaemia, and for this reason, patient received no corrective treatment for ocular vascular disorder. Patient did not recover from vascular ocular disorder. Additionally, on unknown date, patient experienced urinary infection for two years, which was considered serious due to medically significant reason by the company. Moreover, during the infection patient s glycaemia was 800, it did not decrease and patient's vision had been aggravated. The glucose at 800 was considered serious due to medically significant reason by the company. Information regarding corrective treatments for glycaemia increased, urinary infection and visual impairment was not provided. On unknown date, patient recovered from urinary infection and from glycaemia increased, but did not recover visual impairment. As of (b)(6) 2017, it was reported that injection screw had a problem (product complaint (b)(4) / lot number unknown). It was also provided that the prime was not performed properly. Treatment with human insulin regular and human insulin nph was ongoing. The patient operated the device and it was unknown if she was trained. The device model had been used for unspecified time and the reported device had been used since (b)(6) 2016. The device was not returned to the manufacturer. The reporting consumer related the events of visual impairment and vascular ocular disorder to human insulin regular and to human insulin nph. No further relatedness assessment was provided. Update 08aug2017: additional information received on 07aug2017 from call center was processed within initial case entry. Edit 11aug2017. Case was opened to enter medwatch device fields for device regulatory reporting. Update 19oct2017: additional information received on 18oct2017 from the global product complaint database. Entered device specific safety summary (dsss). Updated the medwatch fields with device information and the european and (b)(6) (eu/(b)(6)) device information. Corresponding fields and narrative updated accordingly.
 
Manufacturer Narrative
Device not returned. Usage concerns resolved, and device was reported to be working properly. This is an initial report. A report will be submitted when the final evaluation has been completed.
 
Event Description
(b)(4). This spontaneous case, reported by a consumer, who contacted the company to report a product complaint and an adverse event, concerns a female patient of unknown age and ethnicity. Medical history and concomitant medications were not provided. The patient received human insulin (rdna origin) regular (humulin r) cartridge and human insulin (rdna origin) nph (humulin n) unknown formulation, both of unknown dose, route, frequency, indication and start date. It was unknown how human insulin nph was delivered. Since (b)(6) 2017, the patient received human insulin regular via humapen luxura half-dose (lot unknown). Since unspecified date, unknown time after beginning treatment with human insulin regular via humapen luxura half-dose and human insulin nph, every time patients glucose increased her eye vessels were bursting (as reported). The event of eye vessels that were bursting were considered serious due to medically significant reason by the company. Laboratorial exams were not provided. Patient s physician stated that nothing could be done regarding the eye vessels and what had been damaged had no way of fixing, but patient should control her glycaemia, and for this reason, patient received no corrective treatment for ocular vascular disorder. Patient did not recover from vascular ocular disorder. Additionally, on unknown date, patient experienced urinary infection for two years, which was considered serious due to medically significant reason by the company. Moreover, during the infection patient 's glycaemia was 800, it did not decrease and patient' s vision had been aggravated. The glucose at 800 was considered serious due to medically significant reason by the company. Information regarding corrective treatments for glycaemia increased, urinary infection and visual impairment was not provided. On unknown date, patient recovered from urinary infection and from glycaemia increased, but did not recover visual impairment. As of (b)(6) 2017, it was reported that injection screw had a problem ((b)(4)). It was also provided that the prime was not performed properly. Treatment with human insulin regular and human insulin nph was ongoing. The patient operated the device and it was unknown if she was trained. The device model had been used for unspecified time and the reported device had been used since (b)(6) 2016. Since the complaint was solved, the return of the device was not expected. The reporting consumer related the events of visual impairment and vascular ocular disorder to human insulin regular and to human insulin nph. No further relatedness assessment was provided. Update 08aug2017: additional information received on 07aug2017 from call center was processed within initial case entry. Edit 11aug2017. Case was opened to enter medwatch device fields for device regulatory reporting.
 
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Brand NameHUMAPEN LUXURA HALF-DOSE PEN
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 Key6835808
MDR Text Key265628048
Report Number1819470-2017-00151
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K063151
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial,Followup
Report Date 11/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMS9673
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/18/2017
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: 08/31/2017 Patient Sequence Number: 1
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