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

Model Number MS9660

Device Problem Poor Quality Image (1408)

Patient Problems Hypoglycemia (1912); Memory Loss/Impairment (1958)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

(b)(4).This report is associated with product compliant: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report an adverse event, concerned a (b)(6) female patient of unknown origin.Medical history included too many hypos over the past 50 years.Concomitant medications included insulin detemir, hydrochlorothiazide/ irbesartan and acetylsalicylic acid all for unknown indication.The patient received insulin lispro (rdna origin) (humalog) cartridge via reusable pen (humapen memoir) 4 units three times a day before meals subcutaneously for treatment of insulin dependent diabetes beginning on 2006 or 2008.Since an unknown date her memory was going due to previous many hypos.On (b)(6) 2016 her blood sugar was 2.7 (units were not provided) and since and unknown date her blood usually ranged between 2 to 30 (units were not provided).The event of blood usually ranged 2 was considered serious due to medical significance.She sometimes missed doses of insulin lispro.On 29jul2016, she reported that her humapen memoir had flashing lines on the screen (product complaint (b)(4)/lot 1203c01).She stored humapen memoir in the fridge.The flashing lines resolved once the humapen memoir was allowed to warm up after being removed from the refrigerator.Information regarding corrective treatments and outcome of the events was not provided.Insulin lispro treatment was continued.The operator of the humapen memoir was the patient and her training status was unknown.The humapen memoir general duration of use was not provided.The suspect device was in use for 12-18 months.The suspect humapen memoir was continued and returned was not expected.The reporting consumer did not provide an assessment of relatedness between the events and insulin lispro and humapen memoir.Update 04aug2016: upon review, this case was opened to update the medwatch and european and canadian required device reporting elements for regulatory reporting.Update 12-aug-2016: additional information received on 10-aug-2016 from the initial reporter added the lot number of 1203c01 and duration of use of 12-18 months for the suspect humapen memoir, and updated the narrative.Update 16aug2016: additional information received on 16aug2016 from the complaint department added the product complaint number lot 1203c01 to the case.The narrative was updated with the complaint number and the complaint description.

Manufacturer Narrative

Narrative field - new, updated and corrected information is referenced within the update statements in narrative field.Please refer to update statement dated 23sep2016 in the narrative field.No further follow up is planned.Evaluation summary a female patient reported the display on her humapen memoir device had flashing lines on the screen.The patient experienced decreased blood glucose.The device was not returned for investigation (batch (b)(4), manufactured march 2012); therefore, the device could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown, however, based upon the patient's description, a malfunction has not been confirmed.The user manual provides clear instructions of what to do if dashes appear in the dose display.It also states if the pen has been stored in a cold environment (e.G.Refrigerator), to allow the pen to warm to room temperature.If the pen will not reset, lilly or the patient's healthcare professional should be contacted, however, the patient confirmed, that the device continued to function as expected.There is evidence of improper storage.The user manual instructs the patient to not store the pen in the refrigerator as condensation may form inside the pen and damage the electronics.

Event Description

(b)(4).This spontaneous case, reported by a consumer who contacted the company to report an adverse event, concerned a (b)(6) female patient of unknown origin.Medical history included too many hypos over the past 50 years.Concomitant medications included insulin detemir, hydrochlorothiazide/ irbesartan and acetylsalicylic acid all for unknown indication.The patient received insulin lispro (rdna origin) (humalog) cartridge via reusable pen (humapen memoir) 4 units three times a day before meals subcutaneously for treatment of insulin dependent diabetes beginning on 2006 or 2008.Since an unknown date her memory was going due to previous many hypos.On (b)(6) 2016 her blood sugar was 2.7 (units were not provided) and since and unknown date her blood usually ranged between 2 to 30 (units were not provided).The event of blood usually ranged 2 was considered serious due to medical significance.She sometimes missed doses of insulin lispro.On 29jul2016, she reported that her humapen memoir had flashing lines on the screen ((b)(4) lot 1203c01).She stored humapen memoir in the fridge.The flashing lines resolved once the humapen memoir was allowed to warm up after being removed from the refrigerator.Information regarding corrective treatments and outcome of the events was not provided.Insulin lispro treatment was continued.The operator of the humapen memoir was the patient and her training status was unknown.The humapen memoir general duration of use was not provided.The suspect device was in use for 12-18 months.The suspect humapen memoir was continued in use, and not returned.The reporting consumer did not provide an assessment of relatedness between the events and insulin lispro and humapen memoir.Update 04aug2016: upon review, this case was opened to update the medwatch and european and canadian required device reporting elements for regulatory reporting.Update 12-aug-2016: additional information received on 10-aug-2016 from the initial reporter added the lot number of 1203c01 and duration of use of 12-18 months for the suspect humapen memoir, and updated the narrative.Update 16aug2016: additional information received on 16aug2016 from the complaint department added the product complaint number lot 1203c01 to the case.The narrative was updated with the complaint number and the complaint description.Update 23sep2016: additional information received on 23sep2016 from the global product complaint database added the device specific safety summary and manufactured date of the device; added the device was not returned; updated the medwatch and european and canadian required device reporting elements 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: 5889770
• MDR Text Key: 52609664
• Report Number: 1819470-2016-00207
• Device Sequence Number: 1
• Product Code: NSC
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K053563
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9660
• Device Lot Number: 1203C01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2012
• Is the Device Single Use?: Yes
• 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: 69 YR