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

Model Number MS9673A

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Hyperglycemia (1905)

Event Date 05/31/2018

Event Type  Injury  

Manufacturer Narrative

If device is returned, evaluation will be performed to determine if a malfunction has occurred.A follow-up report will be submitted when the final evaluation is completed as necessary.This device was associated with an increased blood glucose on an unknown date and decreased blood glucose on a separate unspecified date in (b)(6) 2018.

Event Description

(b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and product complaints (pc), concerned a (b)(6) (at the time of initial report) female patient of an unspecified origin.Medical history included diabetes since 2014.Concomitant medication included insulin glargine for an unknown indication.The patient received insulin lispro (rdna origin) (humalog, 100 u/ml) through a cartridge via a reusable pen humapen luxura half dose (hd) at an unknown dose and frequency via an unknown route of administration for the treatment of an unknown indication, beginning on an unknown date.On an unknown date, after starting insulin lispro treatment, her blood sugars was over 2000 (units and reference range not provided) and she went to the hospital.The event blood glucose increased was considered as serious due to medical significance reason.Her a1c (glycosylated hemoglobin) was over 10 (units and reference range not provided).On an unknown date, when she came back from school, her blood glucose was 530.Sometime in (b)(6) 2018, her blood glucose dropped to 40 and she was given so much of juice, (b)(6) and candy so that her blood glucose should came up.The event blood glucose decreased was considered as serious due to medical significance reason.Also, her two out of four cartridges were broken in the box.She received the box from pharmacy on (b)(6) 2018 and the box was sealed.Her mother opened the seal and the box had only four cartridges instead of five.The top part of the cartridge where the red septum was and the glass was broken and missing.(pc# for cartridge (b)(4), lot# c745492d; (b)(4), lot# c787549a; (b)(4), lot# unknown; (b)(4), lot# c815601c).Information regarding corrective treatment for remaining events and outcome of all the events was not provided.Insulin lispro treatment was continued.The operator of the humapen luxura hd was unknown and his/ her training status was not provided.The humapen luxura hd general duration of use and the suspect humapen luxura hd device duration of use were not reported.The actions taken with the suspect humapen luxura hd was not provided and its return was expected.The reporting consumer did not provide any opinion of relatedness between events and insulin lispro and humapen luxura hd.Edit 25may2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 01jun2018: (b)(4) for the humapen luxura half-dose device was added for expedited device reporting.Edit 01jun2018: updated medwatch fields for expedited device reporting.No new information added.

• 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: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 7566644
• MDR Text Key: 110069902
• Report Number: 1819470-2018-00098
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00300029673019
• UDI-Public: 00300029673019
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2018
• 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
• Patient Outcome(s): Other
• Patient Age: 13 YR