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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 Improper or Incorrect Procedure or Method (2017)
Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Coma (2417); Patient Problem/Medical Problem (2688)
Event Date 01/09/2020
Event Type  Injury  
Manufacturer Narrative
Narrative field: new, updated and corrected information is referenced within the update statements. Please refer to update statement dated (b)(6) 2020. No further follow-up is planned. Evaluation summary: the reporter stated the patient used the humapen luxura device for about nine years. There was no product complaint for the device and the device was not returned for investigation. There was evidence of improper use of the device. It was reported that the device was used for about nine years. The user manual states humapen luxura has been designed to be used for up to 6 years after first use.
 
Event Description
Lilly case id: (b)(6). This spontaneous case, reported by a consumer, who contacted the company to report an adverse event, with additional information reported by two other consumers and by a pharmacist, concerns a male patient of unknown age and origin. The medical history of patient included that the pancreas died and he lived in base of insulin and his case was in base of transplant (as reported) (unclear if this procedure was performed) and insulin resistance. The concomitant medications were not reported. The patient received insulin lispro 50% lispro, 50% npl (humalog mix50) cartridge via humapen luxura burgundy, 30 iu at 06h00 am (each morning), 30 iu at 12h00 pm, 12 iu between 06h00 and 08h00 pm and 16 iu between 09h00 and 10h00 pm (each evening),unknown route of administration, for diabetes type 1, beginning around 2016, reported on (b)(6) 2020 as four years ago. On unknown date, unknown if prior or after beginning insulin lispro 50% lispro, 50% npl, the patient was very unwell and an ambulance was called because the patients diabetes type 1 was very aggressive and it was reaching 700. The event of blood glucose increased was considered serious by the company due to medically significant reasons. As corrective measure, the patient was performing a dehydration treatment to see if the blood glucose decreased. It was also reported that on (b)(6) 2019, the pharmacy dispensed insulin lispro (humalog) cartridge instead of insulin lispro 50% lispro, 50% npl which was noticed by the reporter on (b)(6) 2020. Further details were not reported. Additionally, it was reported that the patient was feeling unwell, cold and pale since on unknown date because he had not been taking insulin for four days. As of (b)(6) 2020, the patient was not recovered from feeling unwell, cold, pale and drug dose omission, and it was unknown the outcome of the remaining events. Also on (b)(6) 2020, it was reported the patient was without receiving the insulin due to this issue and was hospitalized in a coma with his blood glucose above 500 (conflicting information; also reported as 386; unclear if the patient was hospitalized and the exact number of blood glucose levels), but was released on the same day at night (reported as blood glucose was 376). It was also reported the patients blood glucose levels were still elevated. Units and normal ranges were not provided for the blood glucose levels. As of (b)(6)2020, it was reported that with a insulin lispro (50% lispro, 50% npl) dose of 16 iu, blood glucose was very low, reported as 60mg /dl (normal range was not provided). Furthermore, patients physician said to patients mother that the insulin lispro (50% lispro, 50% npl) controlled althought did not lower blood glucose. It was one of the insulins that had an effect to lower blood glucose when it was high (600 or 550 mg/dl) but it did not control (conflicting information). It was unknown if patient had experienced blood glucose as 600 or 550 mg/dl. Additionally, insulin lispro (50% lispro, 50% npl) cartridge was stored inside of a box in the refrigerator. No further information was provided. Information regarding corrective treatment was not provided. The status of insulin lispro 50% lispro, 50% npl therapy was unknown. Information regarding the operator of the device and status of training was not provided. It was unknown how long the humapen luxura model had been used. The reported device had been used for about nine years. Status of device was unknown and its return was not expected since there was no product complaint for it. The suspect humapen luxura (burgundy) device was not returned to the manufacturer. The reporting pharmacist and consumers did not provide any opinion of relatedness. This case is cross referenced with the case (b)(6) (same patient). Update 13jan2020: additional information received from initial reporter on (b)(6) 2020 was processed within initial case entry. Update 15jan2020: additional information received from three additional consumers on (b)(6) 2020. Added two additional consumers and a pharmacist as reporters; new serious event of hyperglycemic coma; updated description as reported of the event drug dose omission. Narrative and corresponding fields were updated accordingly. Update 21jan2020: additional information received on (b)(6) 2020 from the initial reporting consumer. Added psp as intermediary. Added patients address, city, state and postal code. Added insulin resistance as medical history. Added humapen luxura as suspect device. Added, insulin lispro (50% lispro, 50% npl) doses and frequency. Added non-serious event of blood glucose decreased. Added 60mg/dl as a blood glucose result in lab data. Narrative and corresponding fields were updated accordingly. Edit 10feb2020: updated medwatch (b)(6) fields for expedited device reporting. No new information added. Update 13feb2020: entered a device specific safety summary (dsss) for the humapen luxura burgundy device. Updated medwatch (b)(6) fields for expedited device reporting. Corresponding fields and narrative updated accordingly.
 
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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
Manufacturer (Section G)
PHILLIPS-MEDISIZE CORPORATION
medical device manufacturing
415 red cedar street
menomonie, wi
Manufacturer Contact
chris davis
lilly corporate center
indianapolis, in 
4334585
MDR Report Key9707580
MDR Text Key192425008
Report Number1819470-2020-00014
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,foreig
Type of Report Initial
Report Date 02/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS9662
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/15/2020
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: 02/13/2020 Patient Sequence Number: 1
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