MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN LUXURA BURGUNDY; FOR TREATMENT PURPOSES

Model Number MS9662

Device Problems Device Operates Differently Than Expected (2913); Difficult to Advance (2920)

Patient Problems Test Result (2695); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

No further follow up is planned.Evaluation summary: a female patient reported the injection button on her humapen luxura device "was difficult to push down, without making clicking sounds." she experienced abnormal blood glucose levels.The device was not returned for investigation (batch number unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.All humapen luxura devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy with high probability.There is no evidence of improper use or storage.

Event Description

(b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) asian female patient.Medical history included allergy to penicillin and streptomycin.Concomitant medication included metformin hydrochloride for an unspecified indication.The patient received insulin lispro protamine suspension 50% insulin lispro 50% (rdna origin (humalog mix50) via a reusable pen (humapen luxura), 20 iu in the morning, 7 iu in the noon and 8 iu in the evening, subcutaneously for the treatment of diabetes and beginning around 2012.Reportedly, the injection button of the humapen luxura was difficult to push down and did not make clicking sounds (product complaint (b)(4), batch unknown).Sometime, she experienced unstable blood sugars and cerebrovascular jam.Due to these events, she was hospitalized for ten days.Laboratory findings and hospitalization dates were not provided as well as corrective treatments and the outcome of the events.Insulin lispro protamine suspension therapy was ongoing.The user of the humapen luxura and his/her training status were not provided.She had used this type of device since 2012 (conflicting information of 2009).The humapen luxura was not returned to the manufacturer.The reporting consumer did not know if the events were related to insulin lispro protamine suspension therapy and did not provide any assessment for the humapen luxura.Edit 28mar2017.Case was opened to enter medwatch device fields and european/canadian device fields for device mailing.No new information.Update 30-mar-2017: additional information received from local affiliate on 28-mar-2017, without information from reporter because after several calls the reporter refused to pick up the phone.No additional changes were made to the case.Update 05-apr-2017: additional information received from local affiliate on 01-apr-2017 stated that the consumer was busy and could not receive follow up.No other changes were made to the case.Update 11-apr-2017: pc (b)(4) was received on 11-apr-2017.Processed pc accordingly and added to narrative.Updated device type from humapen unknown type to humapen luxura burgundy.No further changes were performed to the case.Update 14apr2017: additional information received on 14apr2017 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information and the european and canadian (eu/ca) device information.Corresponding fields and narrative updated accordingly.

• Brand Name: HUMAPEN LUXURA BURGUNDY
• 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: 6499781
• MDR Text Key: 73022521
• Report Number: 1819470-2017-00064
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K142518
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial
• Report Date: 04/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MS9662
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/23/2017
• 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
• Treatment: INSULIN LISPRO; MELBIN
• Patient Outcome(s): Hospitalization
• Patient Age: 72 YR
• Patient Weight: 58