MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN SAVVIO 3ML (RED); FOR TREATMENT PURPOSES

Model Number MS9694

Device Problem Naturally Worn (2988)

Patient Problems Chest Pain (1776); Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908)

Event Type  Injury  

Manufacturer Narrative

No further follow-up is planned.Evaluation summary: a female patient reported the pen spring of her humapen savvio device was worn out and she did not know whether she gave herself the correct dose.She experienced abnormal blood glucose.The device was not returned to the manufacturer for investigation (batch unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.All humapen savvio 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

Lilly case id: (b)(4).This report is associated with product compliant: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), with additional information from a nurse via a psp, concerned a caucasian female patient of an unknown age.Medical history and concomitant medications were not reported.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) (humalog mix 50) through an unknown formulation via a reusable pen humapen savvio (color-red), for the treatment of diabetes type 2, since 2014 approximately.Dosage regimen, route of administration and indication for use were not provided.On an unknown date, she received 30 unspecified units at breakfast, 10 unspecified units at lunch and 20 unspecified units at supper subcutaneously.On an unspecified date, she was admitted due to her blood sugar was uncontrolled because her red humapen savvio pen spring was worn out and she did not known whether she was given herself the correct dose (product complaint (b)(4), lot number unknown) (values, units and reference range not provided), chest pain and uncontrolled hypertension.No more details regarding admission and discharge dates as well as treatment and laboratory tests done while hospitalized were provided.She had not recovered from the blood sugar levels abnormal and possible incorrect dose administered.Information regarding any corrective treatment and outcome of the remaining events was not provided.Insulin protamine suspension 50%/insulin lispro 50% was continued.The operator of the humapen savvio red was the patient and her training status was unknown.The humapen savvio model duration of use and the suspect humapen savvio red duration of use were not reported.The action taken with suspect humapen savvio red was not provided and its return status was unknown.The reporting consumer did not provide a relatedness of blood sugar abnormal with insulin lispro protamine suspension 50%/insulin lispro 50% treatment and did relate blood sugar abnormal to current humapen savvio complaint.The reporting nurse did not provide a relatedness assessment between the events to insulin lispro protamine suspension 50%/insulin lispro 50% therapy, related the event of possible incorrect dose to humapen savvio red but did not provide a relatedness assessment between the remaining events to suspect drug.Update 20-sep-2019: additional information was received from a reporting nurse via a psp on (b)(6) 2019 that upgraded the case to serious.Added a reporting nurse, patient initials, patient details, random fasting blood glucose as new lab data information, ongoing box for suspect drug; second, third and fourth dosage regimen tabs, seriousness criteria for the event of blood sugar abnormal, two serious events of uncontrolled hypertension and chest pain and a new non-serious event of possible incorrect dose administered.Updated indication for use from drug use for unknown indication to diabetes type 2, start date of suspect drug from unknown to 2014, action taken from unknown to no change, operator of device from unknown to patient, outcome of blood sugar abnormal from unknown to not recovered and narrative with new information.Edit 01oct2019: updated medwatch fields for expedited device reporting.No new information added.Update 08oct2019: additional information received on 08oct2019 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information and the (b)(4) device information for the suspect humapen savvio red device associated with product compliant (b)(4), which was not returned to the manufacturer.Corresponding fields and narrative updated accordingly.

• Brand Name: HUMAPEN SAVVIO 3ML (RED)
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer (Section G): TECH GROUP NORTH AMERICA INC. DBA WEST; 640 south rockford drive; tempe AZ 85281
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 9168037
• MDR Text Key: 172924737
• Report Number: 1819470-2019-00181
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K160668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9694
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2019
• 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 Weight: 65