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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 Problems Crack (1135); Inaccurate Delivery (2339); Application Program Problem: Medication Error (3198)
Patient Problems Hypoglycemia (1912); Discomfort (2330); Coma (2417); Sweating (2444)
Event Date 07/31/2017
Event Type  Injury  
Manufacturer Narrative
New, updated and corrected information is referenced within the update statements. Please refer to update statement dated 23oct2017. No further follow-up is planned. Evaluation summary: a female patient reported that her humapen luxura device administered an inaccurate dose and the trim ring was cracked. The patient experienced decreased blood glucose and coma. Investigation of the returned device (0601b03, manufactured january 2006) found the device met functional requirements and met dose accuracy and glide (injection) force specifications. No malfunction was identified. The investigation also found the cartridge holder trim ring was broken due to exposure to an unknown chemical while in the field, not related to the manufacturing process. The user manual instructs, "do not use alcohol, hydrogen peroxide, bleach, cover in liquid or apply lubrication such as oil, as this could damage the pen. " it further instructs to not use the device if it appears broken or damaged and to contact lilly or your healthcare professional for a replacement pen. There is evidence of improper use or storage. The breakage on the device due to exposure to an unknown chemical occurred while in the field (not related to the manufacturing process). This damage is not likely related to the event of decreased blood glucose and coma as the device met dose accuracy specifications.
 
Event Description
Lilly case id: (b)(4). This spontaneous case, reported by a consumer who contacted the company to report adverse events and product complaint (pc), concerned an (b)(6) female patient. Medical history included hypertension. Concomitant medications included acarbose for an unknown indication. The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) (humalog 25, 300 units/3ml) from a cartridge via humapen luxura (burgundy) pen, 13 units in morning and 11 units at night, subcutaneously, for the treatment of diabetes mellitus, beginning in 2006. In (b)(6) 2017, the trim ring of the humapen luxura (burgundy) was cracked and she was administered inaccurate dose (pc number (b)(4), lot number 0601b03). On an unspecified date in middle of (b)(6) 2017, during 11:00 p. M. To 12:00 p. M. , she experienced cold sweating and discomfort. It was thought that it might be low blood glucose (no values or units or reference ranges were provided) and she was given 150ml water dissolved with three spoons of glucose powder, then she went into coma. Ambulance was called and her blood glucose was measured as 2. 1 (no units or reference ranges were provided). The events of low blood glucose and coma were considered serious due to their medical significance. After that she discontinued insulin lispro protamine suspension 75%/insulin lispro 25%. Information regarding corrective treatment for the remaining events and outcome of events was not reported. She did not retake insulin lispro protamine suspension 75%/insulin lispro 25%. The user of the device and his/ her training status was not provided. She had used this type of device since 2006 and discontinued in (b)(6) 2017; 11 years duration of use. The suspect device, which was manufactured in jan2006, was returned to the manufacturer on 05sep2017. Upon investigation, it was noted that the device was working properly; however, the trim ring was broken due to an exposure to an unknown chemical while in the field. The reporting consumer assessed the relatedness between the events and insulin lispro protamine suspension 75%/insulin lispro 25% as unknown. Update 21sep2017: updated medwatch fields for expedited device reporting. No new information added. Update 23oct2017: additional information received on 23oct2017 from the global product complaint database. Entered device specific safety summary (dsss). Updated the medwatch/european and (b)(6) (eu/(b)(6)) device information, improper use and storage from no to yes, malfunction from unknown to no, and device return status to returned to manufacturer. Added date of manufacturer and date returned to manufacturer for the device with pc (b)(4) associated with lot 0601b03 of the humapen luxura (burgundy) device. Corresponding fields and narrative updated accordingly.
 
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 adverse events, concerned an (b)(6) female patient. Medical history included hypertension. Concomitant medications included acarbose for an unknown indication. The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) (humalog 25, 300 units/3 ml) from a cartridge via humapen luxura, burgundy colour, 13 units in morning and 11 units at night, subcutaneously, for the treatment of diabetes mellitus, beginning in 2006. In (b)(6) 2017, the trim ring of humapen luxura was cracked and she was administered inaccurate dose ((b)(4), lot number 0601b03). On an unspecified date in middle of (b)(6) 2017, during 11:00 p. M. To 12:00 p. M. , she experienced cold sweating and discomfort. It was thought that it might be low blood glucose (no values or units or reference ranges were provided) and she was given 150 ml water dissolved with three spoons of glucose powder, then she went into coma. Ambulance was called and her blood glucose was measured as 2. 1 (no units or reference ranges were provided). The events of low blood glucose and coma were considered serious due to their medical significance. After that she discontinued insulin lispro protamine suspension 75%/insulin lispro 25%. Information regarding corrective treatment for the remaining events and outcome of events was not reported. She did not retake insulin lispro protamine suspension 75%/insulin lispro 25%. The user of the device and his/ her training status was not provided. She had used this type of device since 2006 and discontinued in (b)(6) 2017. The return status of the pen was unknown. The reporting consumer assessed the relatedness between the events and insulin lispro protamine suspension 75%/insulin lispro 25% as unknown. Update 21sep2017: 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
caroline rosewell
lilly corporate center
indianapolis, IN 46285
3172764376
MDR Report Key6895647
MDR Text Key267701077
Report Number1819470-2017-00171
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 consumer,foreign
Type of Report Initial,Followup
Report Date 11/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberMS9662
Device Lot Number0601B03
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/05/2017
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/23/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/31/2006
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: 09/26/2017 Patient Sequence Number: 1
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