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

Model Number MS9660

Device Problems Use of Device Problem (1670); Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

(b)(4).This device case, which does not involve an adverse event, reported by a consumer who contacted the company to report a product complaint, regards a male patient of unspecified age and origin.The patient was taking an unknown medication for an unknown indication.On (b)(6) 2015, it was reported that the patient's humapen memoir had missing segments in the time and dose display.The device was stored in the refrigerator.The humapen memoir was associated with product complaint (b)(4)/ lot 1308c02.The patient was the user of the device.The training status was not provided.The duration of use was not provided.The return of the device was requested.Update 15may2015: additional information was received on 15may2015 from the product complaint safety database.Lot number unknown was corrected to 1308c02 for product complaint (b)(4).The product tab for humapen memoir and the narrative were updated with the change.

Manufacturer Narrative

This is an initial report.A follow-up report will be submitted when the final evaluation is completed.

Manufacturer Narrative

No further follow up is planned.Evaluation summary a patient reported that his humapen memoir device had missing segments in the time and dose display.Investigation of the returned device (batch 1308c02, manufactured august 2013) confirmed missing segments in the dose, date and time display due to a damaged conductor within the lcd interconnect cable.The reportable malfunction missing dose number segments may result in an inaccurate dose of insulin.Malfunction confirmed.A house sample review of the batch was completed and no issues regarding missing segments in the display were observed.A batch record review confirmed that the batch had no indication of an issue with missing segments in the dose numbers or the date/time.The user would typically be aware of missing dose number segments.When the pen is powered on, all segments of the display are illuminated to confirm proper function.The user manual instructs that if any part of the pen display is missing do not use pen.It further instructs that if the display is not working correctly to contact lilly or your healthcare professional.Corrective action - an improvement was implemented to add a visual inspection for the lcd cable loop position for station 12 and reject any cables which appear to be looped under the lcd glass.The new control was added beginning with batch 1404c02 (manufactured april 2014).This is the first report for this particular failure mode on this batch.Due to its rare occurrence and adequate warnings in the user manual, no additional corrective action is planned at this time.This humapen memoir device was manufactured prior to the implemented corrective action.There is evidence of improper use.The user stored the device in the refrigerator.

Event Description

(b)(4).This device case, which does not involve an adverse event, reported by a consumer who contacted the company to report a product complaint, regards a male patient of unspecified age and origin.The patient was taking an unknown medication for an unknown indication.On (b)(6) 2015, it was reported that the patient's humapen memoir had missing segments in the time and dose display.The device was stored in the refrigerator.The humapen memoir was associated with product complaint (b)(4)/ lot 1308c02.The patient was the user of the device.The training status was not provided.The duration of use was not provided.The device was returned on 15may2015.Update 15may2015: additional information was received on 15may2015 from the product complaint safety database.Lot number unknown was corrected to 1308c02 for product complaint (b)(4).The product tab for humapen memoir and the narrative were updated with the change.Update 01jul2015: additional information received on 30jun2015 from the global product complaint database added the device specific safety summary, manufactured date of the device, and return date of the device; updated the medwatch and eu/ca fields; and updated the narrative.

• Brand Name: HUMAPEN MEMOIR
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer (Section G): NYPRO, INC.; 101 union street; clinton MA 01510
• Manufacturer Contact: caroline rosewell ; lilly corporate center; indianapolis, IN 46285 ; 3172764376
• MDR Report Key: 4790128
• MDR Text Key: 16186260
• Report Number: 1819470-2015-00035
• Device Sequence Number: 1
• Product Code: NSC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K053563
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MS9660
• Device Lot Number: 1308C02
• Other Device ID Number: 3316095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2013
• 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