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

Model Number MS9673A

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Diabetic Ketoacidosis (2364)

Event Date 07/31/2017

Event Type  Injury  

Manufacturer Narrative

Narrative field; new updated and corrected information is referenced within the update statements please refer to statement dated (b)(6) 2017.No further follow up is planned.Evaluation summary: the reporter stated the patient used the humapen luxura half-dose (hd) when it contained an expired saline cartridge.The saline cartridge reportedly had not been removed during the clinic visit.They brought the device home from their clinic visit and used the device without obtaining the prescribed insulin cartridges.

Event Description

Lilly case id: (b)(4).This regulatory authority case, reported by a health care professional (hcp) via regulatory agency, with additional information received from affiliate, concerned a (b)(6) black female patient.Medial history included type i diabetes mellitus diagnosed in (b)(6) 2011.Concomitant medication included insulin glargine for an unknown indication.The patient received insulin lispro (rdna origin) injections (humalog) via pre-filled pen (kwikpen).Dosage regimen, route of administration, indication for use and start therapy date were not provided.It was reported that in (b)(4) 2017 she had her first diabetic ketoacidosis (dka) event and was admitted to hospital.No more details regarding admission (exact date) and discharge dates as well as treatment and laboratory tests done while hospitalized were provided.Since an unspecified date, insulin lispro via kwikpen was changed to a humapen luxura half-dose (hd) device (it was unclear if she would continue taking insulin lispro or another insulin) for insurance reasons.On (b)(6)2017, while using the humapen luxura hd, she experienced dka and was admitted to intensive care unit (icu); she responded quickly to an unspecified treatment and was transferred to acute care unit and was discharged home (unknown date).When the cartridge in the humapen luxura hd was checked, they realized that it was a saline cartridge that is used for teaching purposes, and it was not the insulin cartridge she had to administer.Information regarding corrective treatment and outcome of the events was not provided.It was unknown if she would restart insulin lispro kwikpen and the status of the humapen luxura hd and the saline solution was unknown.The operator of the kwikpen and the humapen luxura hd was unknown and its training status was not provided.The general and the suspect kwikpen and humapen luxura hd duration of use were not reported.The suspect kwikpen and humapen luxura hd were not returned to the manufacturer.The reporting hcp did not provide an assessment of relatedness between the events and insulin lispro, saline solution or the humapen luxura hd.Update 17-oct-2017: additional information was received from the affiliate on 13-oct-2017, product complaint number received.Edit (b)(6) 2017: upon internal review of the information received on 05-sep-2017, the improper use for the humapen luxura hd was changed from no to yes.No new information was received.Update (b)(6) 2017: additional information received on 31oct2017 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields and european and canadian (eu/ca) device information for the suspect humapen luxura hd.Corresponding fields and narrative updated accordingly.

• 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: 7001339
• MDR Text Key: 91112385
• Report Number: 1819470-2017-00177
• 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: Other
• Type of Report: Initial
• Report Date: 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9673A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/05/2017
• 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 Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 10 YR
• Patient Weight: 31