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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 Inaccurate Delivery (2339); Gas Leak (2946)
Patient Problem Hyperglycemia (1905)
Event Date 08/31/2018
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 an adverse event, concerned an (b)(6) male patient of unknown origin. Medical history and concomitant medications were not reported. The patient received insulin lispro (rdna origin) injections (humalog u100) cartridges, via reusable pen (humapen unknown). Dosage regimen, route of administration, indication for use and start date were not reported. Sometime around late (b)(6) 2018 or (b)(6) 2018, bubbles in the insulin lispro cartridges were noted, therefore, he did not received his full insulin lispro dose ((b)(4); lot. No. Unknown), causing his blood sugars to spike (once to 600 with no units or reference values). This event was considered to be serious due to medical significance. Once those cartridges were replaced, his blood sugars would return to normal. Information regarding corrective treatments, outcome of the events and insulin lispro status was not reported. The operator of the humapen was the patient and his training status was not provided. The humapen model duration of use was not provided. The reported humapen duration of use was not provided. The status of the humapen was unknown. The reporting consumer did not provide an assessment of relatedness between the events and the insulin lispro treatment nor did provide an assessment of relatedness between the events and the humapen. Edit 05oct2018: updated medwatch and european and (b)(6) fields for expedited device reporting. No new information added. Edit 08-oct-2018. Upon internal review, the type of the humapen was updated from luxura hd to unknown. Updated narrative 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 st.
menomonie WI 54751
Manufacturer Contact
chris davis
lilly corporate center
indianapolis, IN 46285
3174334585
MDR Report Key7948889
MDR Text Key123197193
Report Number1819470-2018-00180
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063151
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMS9673A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/29/2018
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: 10/09/2018 Patient Sequence Number: 1
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