MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN LUXURA HALF-DOSE PEN; FOR TREATMENT PURPOSES

Model Number MS9673A

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Hypoglycemia (1912); Overdose (1988)

Event Type  Injury  

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 pharmacist, who contacted the company to report adverse events, concerns a pediatric patient of unspecified age or gender.Information about medical history was not provided.Concomitant medications included insulin glargine for an unspecified indication.The patient received insulin lispro (rdna origin) injections from a cartridge (100 u/ml: 3ml), via a humapen luxura half dose (hd), half a unit at meal times as needed based on sliding scale and a maximum of 10 units per day, for the treatment of type i diabetes, beginning on (b)(6) 2015.When the medication was applied using the humapen device, the blood readings were not consistent because they could not get an accurate dose (lot unknown).If the patient was trying to get one unit, the one unit seemed to be different each time because of the small residue that seemed to be left in the small little needle.It was stated that for a big person this probably would not matter; however for a pediatric patient it made a big difference.As a result the mother started using an insulin syringe to inject the insulin lispro.It was also stated that half a unit of insulin lispro was too much as the blood sugar of the patient was sometimes possibly below 40 (no units were provided).The patient had a continuous glucose monitoring system that stopped reading at 40.The event of low blood sugar was considered serious for medical significance.Information about corrective treatments and outcome of the events was not provided.By (b)(6) 2016, insulin lispro treatment was continued.The mother of the patient was the user of the reusable humapen device.Her training status was not provided.The suspect device duration of use was unknown but it started on (b)(6) 2015.Its use had been discontinued.The status of the device was not provided.The reporting pharmacist did not provide an opinion of causality between the events and insulin lispro medication or device; however the mother of the pediatric patient considered that the events were due to the insulin lispro medication as the administered dose was too high.Update 15apr2016: upon review, this case was opened to updated the improper use and storage for the humapen luxura hd to no; updated the medwatch fields for regulatory reporting; updated the preliminary comments; and updated the narrative.

Manufacturer Narrative

New, updated and corrected information is referenced within the update statements.Please refer to update statement dated 24may2016.No further follow up is planned.Evaluation summary the pharmacist reported on behalf of a pediatric patient that the patient's blood readings were not consistent because they could not get an accurate dose when using a humapen luxura hd device.The mother of the patient reported that "they have been giving the patient half a unit and in the past 3 days, that's still too much." the patient experienced decreased blood glucose levels.The device was not returned for investigation (batch unknown).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.There is no evidence of improper use or storage.

Event Description

(b)(4).This spontaneous case reported by a pharmacist, who contacted the company to report adverse events, concerns a pediatric patient of unspecified age or gender.Information about medical history was not provided.Concomitant medications included insulin glargine for an unspecified indication.The patient received insulin lispro (rdna origin) injections from a cartridge (100 u/ml: 3ml), via a humapen luxura half dose (hd), half a unit at meal times as needed based on sliding scale and a maximum of 10 units per day, for the treatment of type i diabetes, beginning on (b)(6)-2015.When the medication was applied using the humapen device, the blood readings were not consistent because they could not get an accurate dose (lot unknown).If the patient was trying to get one unit, the one unit seemed to be different each time because of the small residue that seemed to be left in the small little needle.It was stated that for a big person this probably would not matter; however for a pediatric patient it made a big difference.As a result the mother started using an insulin syringe to inject the insulin lispro.It was also stated that half a unit of insulin lispro was too much as the blood sugar of the patient was sometimes possibly below 40 (no units were provided).The patient had a continuous glucose monitoring system that stopped reading at 40.((b)(4) batch lot number unknown).The event of low blood sugar was considered serious for medical significance.Information about corrective treatments and outcome of the events was not provided.By (b)(6)-2016, insulin lispro treatment was continued.The mother of the patient was the user of the reusable humapen device.Her training status was not provided.The suspect device duration of use was unknown but it started on (b)(6)-2015.Its use had been discontinued.The device was not returned.The reporting pharmacist did not provide an opinion of causality between the events and insulin lispro medication or device; however the mother of the pediatric patient considered that the events were due to the insulin lispro medication as the administered dose was too high.Update 15-apr-2016: upon review, this case was opened to updated the improper use and storage for the humapen luxura hd to no; updated the medwatch fields for regulatory reporting; updated the preliminary comments; and updated the narrative.Update 26-apr-2016: no new information provided.No changes performed in the case.Edit 29-apr-2016: (b)(4) was received on 08-apr-2016.Processed and added to narrative.No other changes were performed in the case.Update 24may2016: additional information received on 23may2016 from the global product complaint database added the device specific safety summary; added the device was not returned; updated the medwatch and (b)(6) required device reporting elements; and updated the narrative.Update 30-may-2016: product complaint number was received on 25-may-2016 and was already added in narrative.No new adverse event or product information was received.

• Brand Name: HUMAPEN LUXURA HALF-DOSE PEN
• Type of Device: FOR 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 Key: 5597479
• MDR Text Key: 43323116
• Report Number: 1819470-2016-00097
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 04/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MS9673A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: LANTUS
• Patient Outcome(s): Other