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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 Hyperglycemia (1905); Hypoglycemia (1912); Nausea (1970)
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 report is associated with product compliant: pending. This spontaneous case, reported by a consumer who contacted the company to report an adverse event and a product complaint (pc), with additional information from the initial reporter, concerned a male patient of unknown age and origin. Medical history and concomitant medications were not provided. The patient received an unspecified insulin via a humapen luxura (unknown body type), subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date. Dose and frequency were not provided. On an unknown date after beginning the use of the humapen luxura, he experienced that the dosing knob can no longer be pushed(lot number unknown, (b)(4)). On an unknown date after beginning the use of the humapen luxura, his blood glucose increased because of device issue. Since unknown date, he injected more than 50 ius of insulin, otherwise it had no effect. He also injected sometimes too much insulin and his blood glucose went down to 30 mg/dl (this event was considered serious due to medical significance); as a consequence he developed nausea. The humapen luxura that he used was reported to be defective (pc/lot unknown). Outcome of the events, information regarding corrective treatment and status of the unspecified insulin and status of humapen luxura were not provided. The operator of the humapen luxura device and his/her training status was unknown. The device model, duration of use was not provided but was started on an unspecified date and the suspect device duration of use was not reported. The action taken with the humapen luxura device and its return status was not reported. The reporting consumer did not provide the relatedness assessment for the events with humapen luxura. Update 22-feb-2018: additional information received on 31-jan-2018 from the initial reporter. Added serious event of blood glucose decreased and non serious event of wrong dose administered. Also added new suspect humapen luxura and concomitant insulin. Narrative and fields were updated accordingly. Update 26feb2018: updated medwatch fields for expedited device reporting. No new information added. Edit 26-feb-2018: recoded suspect devices from humapen luxura hd to humapen luxura unknown body type. No other changes performed. Update 01mar2018: updated medwatch fields for expedited device reporting. No new information added.
 
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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
chris davis
lilly corporate center
indianapolis, IN 46285
3174334585
MDR Report Key7307741
MDR Text Key101342140
Report Number1819470-2018-00027
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 04/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberMS9673
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/27/2018
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: 03/01/2018 Patient Sequence Number: 1
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