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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 Mechanical Jam (2983)
Patient Problems Hyperglycemia (1905); Coma (2417)
Event Date 06/09/2021
Event Type  Injury  
Manufacturer Narrative
New, updated, and corrected information is referenced within the update statements. Please refer to update statement(s) dated 07jul2021. No further follow-up is planned. Evaluation summary a female patient reported that on (b)(6) 2021, her humapen luxura hd device "got impaired, became very heavy to press, and was releasing the insulin dose drop by drop. " on (b)(6) 2021, she experienced hyperglycemia. The device was not returned to the manufacturer for investigation (batch number 1201g07, manufactured january 2012). 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. A complaint history review did not identify any atypical findings with regard to injection force high or pen jam issues, and the batch threshold review did not identify any atypical findings with regard to dose accuracy issues. There is no evidence of improper use or storage.
 
Event Description
Lilly case id: (b)(4). This report is associated with product complaint: (b)(4). This solicited case reported by a consumer via patient support program (psp), concerned a (b)(6)-years-old female patient with an unknown origin. Medical history and concomitant medication was not provided. The patient received insulin lispro (rdna origin) injections (humalog 100) from cartridge via a reusable humapen (luxura), for the treatment of diabetes mellitus beginning on an unknown date. Information regarding dosage regimen and route of administration were not provided. She was using humapen since (b)(6) 2018 or (b)(6) 2019 (exact start date was not reported). Since (b)(6) 2021, after starting insulin lispro therapy, she had fever, therefore insulin was not absorbed by her body (her body refused it), which led to high blood glucose levels and she was hospitalized since five days due to hyperglycemic coma and fever (units, value and reference range were not provided). She was now on unknown iv infusions. On (b)(6) 2021, her humapen got impaired, became very heavy to press, and was releasing the insulin dose drop by drop (pc (b)(4)/lot 1201g07). She tried changing the needle and cartridge but nothing changed as the humapen was still stuck. Therefore, since (b)(6) 2021, she had been using insulin lispro (rdna origin) injections (humalog) via a pre-filled pen (kwikpen) for the treatment of diabetes mellitus. Information regarding further corrective treatment, hospitalization details and outcome of the events was not provided. Insulin lispro (humalog cartridge) therapy status after discontinuation was not provided. The operator of humapen was unknown and his or her training status was not provided. The general humapen model duration and suspect humapen duration of use was not provided but it was started two or three years ago (since (b)(6) 2018 or (b)(6) 2019, exact start date was not reported). The suspect device manufactured in jan2012, was not returned to the manufacturer. The reporting consumer did not provide an assessment of relatedness between the event malabsorption from injection site and insulin lispro drug while assessed the relatedness between the remaining events and insulin lispro drug as unknown. The reporting consumer did not provide an assessment of relatedness between the events and humapen device. Edit 24jun2021: updated medwatch fields for expedited device reporting. No new information added. Update 07jul2021: additional information received on 02jul2021 from the global product complaint database. Entered device specific safety summary (dsss). Updated the medwatch fields/ european and (b)(6) device information and device return status not to returned to manufacturer. Added date of manufacturer for pc (b)(4) associated with 1201g07 of humapen luxura hd device. Corresponding fields and narrative 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
chris davis
lilly corporate center
indianapolis, IN 46285
3174334585
MDR Report Key12165877
MDR Text Key261458127
Report Number1819470-2021-00084
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 company representative,consum
Type of Report Initial
Report Date 07/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS9673A
Device Catalogue NumberMS9673
Device Lot Number1201G07
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/14/2021
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: 07/14/2021 Patient Sequence Number: 1
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