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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 MS9673A
Device Problems Retraction Problem (1536); Insufficient Flow or Under Infusion (2182)
Patient Problem Hyperglycemia (1905)
Event Date 11/30/2016
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 device only case, reported by a pharmacist who contacted the company to report adverse events, with additional information from a pharmacist and forwarded by a regulator, concerned a (b)(6) male patient of unknown ethnicity. Medical history was not provided. Concomitant medications included a few unspecified medicines for unknown indications. The patient received an unspecified product via a reusable humapen luxura. Dosage regimen, frequency of administration, indication for use, and start date of treatment were not provided. In (b)(6) 2016 (conflicting information, also reported as approximately in (b)(6) 2016), his blood glucose levels were at a higher level than usual since his humapen luxura had not been working properly ((b)(4), lot number 1603g05). The event of blood glucose increased was considered serious by the regulator. The humapen luxura did not work due to the plunger; it did not return and did not move, and the problem with the humapen luxura seemed to lead to the fact that he was not getting a proper dose and his glucose levels had been going up (no units, values or reference ranges were provided). Information regarding corrective treatment, outcome of the events, and action taken with the unspecified product was not provided. The operator of the humapen luxura was not reported and his/her training status was not provided. The humapen luxura model and reported humapen luxura durations of use were not provided. The suspect humapen luxura was discontinued and changed to a humapen savvio. The reporting pharmacist did not provide an assessment of relatedness between the events and humapen luxura device or the unspecified product.
 
Manufacturer Narrative
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 pharmacist reported on behalf of a male patient that the plunger of his humapen luxura hd device "did not return and did not move. " the pharmacist reported the patient was not getting a proper dose of insulin. The patient experienced increased blood glucose levels. Investigation of the returned device (batch 1603g05, manufactured march 2016) found that the device met functional requirements and met dose accuracy and glide (injection) force specifications. No malfunction was identified. There is no evidence of improper use or storage.
 
Event Description
(b)(4). This spontaneous device only case, reported by a pharmacist who contacted the company to report adverse events, with additional information from a pharmacist and forwarded by a regulator, concerned a (b)(6) male patient of unknown ethnicity. Medical history was not provided. Concomitant medications included a few unspecified medicines for unknown indications. The patient received an unspecified product via a reusable humapen luxura half dose (hd). Dosage regimen, frequency of administration, indication for use, and start date of treatment were not provided. In late (b)(6) 2016 (conflicting information, also reported as approximately in (b)(6) 2016), his blood glucose levels were at a higher level than usual since his humapen luxura hd had not been working properly ((b)(4), lot number 1603g05). The event of blood glucose increased was considered serious by the regulator. The humapen luxura hd did not work due to the plunger; it did not return and did not move, and the problem with the humapen luxura hd seemed to lead to the fact that he was not getting a proper dose and his glucose levels had been going up (no units, values or reference ranges were provided). Information regarding corrective treatment, outcome of the events, and action taken with the unspecified product was not provided. The operator of the humapen luxura hd was not reported and his/her training status was not provided. The humapen luxura hd durations of use were not provided. The suspect humapen luxura hd was discontinued and changed to a humapen savvio. The device was returned to the manufacturer on 16feb2017. The reporting pharmacist did not provide an assessment of relatedness between the events and humapen luxura hd device or the unspecified product. Update 14mar2017: additional information received 16feb2017 from the product complaint safety database. On the device tab entered the device return date, manufacture date, changed malfunction to no, entered the device specific safety summary (dsss), updated device name in narrative, updated the european and canadian (eu/ca) device information, updated the medwatch field with the device information and the narrative was updated accordingly.
 
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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 Key6376497
MDR Text Key69015091
Report Number1819470-2017-00051
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 foreign,health professional,o
Type of Report Initial,Followup
Report Date 04/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberMS9673A
Device Lot Number1603G05
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/16/2017
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/13/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/30/2016
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: 03/03/2017 Patient Sequence Number: 1
Treatment
HUMAPEN
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