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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN LUXURA BURGUNDY FOR TREATMENT PURPOSES

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ELI LILLY AND COMPANY HUMAPEN LUXURA BURGUNDY FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9662
Device Problem Mechanical Jam (2983)
Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)
Event Type  Injury  
Manufacturer Narrative
No further follow up is planned. This report is associated with 1819470-2021-00038 since there is more than one device implicated. Evaluation summary: a female patient reported in (b)(6) 2020 that the injection button of her humapen luxura device could not be pushed down. In (b)(6) 2021, the patient reported since sometime in 2016 she was experiencing increased blood glucose and hypoglycemia. The device was not returned to the manufacturer for investigation (batch unknown). Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction. Malfunction unknown. All humapen luxura devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality with high probability. 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 a patient support program (psp), concerned a (b)(6) years-old asian (han) female patient. Medical history included thyroid, hypertension, heart disease and cardiac stenting. Her five sisters, parents and parents respective siblings all had diabetes. Concomitant medications included pioglitazone, metformin and sitagliptin used for the treatment of type ii diabetes mellitus. The patient received insulin lispro (rdna origin) (humalog), via a reusable pen (humapen luxura, burgundy), 18 u in morning, 14 u in night, twice daily, subcutaneously for the treatment of type 2 diabetes mellitus, beginning on an unknown date around 10 to 20 years ago. The patient also received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injections (humalog mix 25), via a reusable pen (humapen luxura, burgundy), 12 u in morning, 8 u in night, twice daily, subcutaneously for the treatment of type 2 diabetes mellitus, beginning on an unknown date. Since an unknown date, while on the insulin lispro protamine suspension 75%/insulin lispro 25% therapy, she experienced unstable blood sugar and poor memory. Since sometime in 2016, after using the insulin lispro and insulin lispro protamine suspension 75%/insulin lispro 25% drugs, her blood glucose was not well controlled and her blood glucose was always on the high side (values, units and reference ranges were not provided), occasionally hypoglycemia due to which she was hospitalized. She also felt discomfort. Both of the two insulin injection pens button could not be pushed down recently (pc number (b)(4), lot number unknown) and (pc number (b)(4), lot number unknown). After changing the needle, the injection button still could not be pushed down and she wanted to get both pens repaired. Both of the pens were presented from shanghai putuo district people hospital several years ago. Information regarding any corrective treatments, further hospitalization details, laboratory tests done while hospitalization and outcome of the events were not provided. Status of the insulin lispro and insulin lispro protamine suspension 75%/insulin lispro 25% drugs was continued. The operator of humapen luxura devices and his/her training status was not provided. The humapen luxura devices general model duration of use and suspect humapen luxura devices duration of use was also unknown. Action taken with the suspect humapen luxura devices was not reported they were not returned to he manufacturer. The initial reporting consumer did not provide any relatedness assessment of the events and the insulin lispro and insulin lispro protamine suspension 75%/insulin lispro 25% drugs and the humapen luxura devices. This case was cross-referenced with the following case (b)(4) (same patient). Update 01-apr-2020: information was received from the initial reporter via psp on 12-mar-2020. Only pc numbers (b)(4) and (b)(4) were received. No medically significant information was received. No changes were made to the case. Update 01-mar-2021: initially this case was considered to be non-serious. Additional information received from initial reporter via (psp) on 23-feb-2021. This case was upgraded to serious due to addition of two new serious events of blood sugar high and hypoglycemia, their corresponding laboratory data, one new non-serious event of discomfort and euca device fields. Added patient demographics and medical history of thyroid and family history of diabetes. Updated the action taken of insulin lispro drug to ongoing. Updated the narrative with new information. Edit 03-mar-2021: upon review the age was updated in the narrative. No other changes were made to the case. Edit 16-mar-2021: upon review the cire report was attached to the case, address of hospital of both pens was added to the euca fields and narrative was updated with pc lot numbers. No other changes were made to the case. Edit 17-mar-2021: upon review the product complaint was described in the narrative as per the attached cire report. Update 21mar2021: additional information received on 15mar2021 from the global product complaint database. Entered the device specific safety summary (dsss). Updated the medwatch and european and canadian (eu/ca) device fields for the suspect devices associated with pc (b)(4) and (b)(4). Corresponding fields and narrative updated accordingly. Edit 23-mar-2021: upon review drug formulation was updated from unknown to cartridge for both suspect drugs and the general tab no longer contained classification us combo product as the devices were reusable. Edit 23mar2021: updated medwatch fields for expedited device reporting. No new information added.
 
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Brand NameHUMAPEN LUXURA BURGUNDY
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 Key11563026
MDR Text Key257879670
Report Number1819470-2021-00037
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K142518
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial
Report Date 03/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS9662
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/23/2021
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: 03/24/2021 Patient Sequence Number: 1
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