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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 Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Code Available (3191)
Event Type  Injury  
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. This report is associated with 1819470-2018-00130 since there is more than one device implicated.
 
Event Description
Lilly case id: (b)(4). This report is associated with product compliant: pending. This spontaneous case, reported by a consumer who contacted the company to report adverse events, concerned a (b)(6) (at the time of initial report) male patient of unknown ethnicity. Medical history included pain and increased blood pressure. Concomitant medications included unspecified pain killers, tilidine hydrochloride, morphine plasters, unspecified blood pressure lowering agents; all for unknown indication. The patient received insulin lispro (rdna origin) (humalog, cartridge) via humapen memoir and insulin glargine (lantus, cartridge) via luxura hd, at unknown doses and frequencies, subcutaneously for the treatments of diabetes mellitus, beginning on unknown dates. On an unknown date after starting insulin lispro and insulin glargine therapies, he did not read the instructions to administer dose from humapen luxura hd and administered wrong amount of insulin. He experienced abnormal blood glucose (units, reference ranges and values were not provided) with three to four sugar shocks due to which he was hospitalized. More information regarding surgical procedures and laboratory tests during hospitalization was not provided. He only primed when a new cartridge was inserted and needles were used until they became dump (improper use). On unknown dates, in the mornings, he frequently had bitter taste in mouth. Corrective treatment was not provided. Outcome of the events was not resolved. Status of insulin lispro and insulin glargine therapies was not provided. Follow up would not be possible because the consent to contact the patient and healthcare professional (hcp) was not gained. The operator of humapen memoir and humapen luxura hd was patient and training status of patient was not provided. The general and suspect humapen memoir and humapen luxura hd models duration of use was not provided as they were started on an unknown date. The action taken with the humapen memoir and humapen luxura hd was not provided and their returns were not expected. The reporting consumer did not provide relatedness assessment between the events and insulin lispro and insulin glargine therapies or their humapen luxura hd and humapen memoir pens. Edit 30jul2018: 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 Key7763952
MDR Text Key116535754
Report Number1819470-2018-00129
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K100988
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial,Followup
Report Date 09/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMS9673A
Device Lot Number1610G01
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2018
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: 08/08/2018 Patient Sequence Number: 1
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