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

Model Number MS9697

Device Problems Sticking (1597); Improper or Incorrect Procedure or Method (2017)

Patient Problems Hypoglycemia (1912); Overdose (1988); Coma (2417)

Event Type  Injury  

Manufacturer Narrative

New updated and corrected information is referenced within the update statements.Please refer to statement dated (b)(6) 2016.No further follow up is planned this report is associated with 1819470-2016-000309, since there is more than one device implicated.Evaluation summary a male patient reported his humapen savvio device "stuck while injecting" and "released extra dose." the patient experienced hypoglycemic coma.The device was not returned to the manufacturer for investigation (batch number 1309v06, manufactured september 2013).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review for the batch did not identify any atypical findings with respect to the complaints of delivers more than selected and dose accuracy.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.The user manual instructs the user to use a new needle for each injection.There is evidence of improper use.The patient reused needles.It is unknown if this is relevant to the event of hypoglycemic coma.

Event Description

Lilly case id: (b)(6).This report is associated with product compliant: (b)(6).This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) male patient of unknown origin.Medical history and concomitant medications were not reported.The patient received human insulin isophane suspension 70%/ human insulin 30% (rdna origin) injections (humulin 70/30) cartridge via reusable pen (humapen savvio pink) and human insulin (rdna origin) injections (humulin r) cartridge via reusable pen (humapen savvio pink).Dosage regimen, indication for use, route of administration and start date were not provided.On an unknown date the humapen savvio was stuck while injecting, after called the dose, while pressing and released the dose, it suddenly got stuck, then it went down quickly (product complaint (b)(6) unknown lot 1309v06) (product complaint (b)(6) lot unknown).The pen released extra dose and it caused him hypoglycemia and also he had blood droplets after injection.On an unspecified time he got comatose because of hypoglycemia, where his fasting blood glucose was 20 mg/dl; however he adjusted the doses and it did not happen this time.The event of he got comatose because of hypoglycemia was considered as serious due to medically significant.His physician asked him to decrease the diameter of needles to decrease the blood droplets came after injection.On an unknown date his dermatologist told him he had multiple lipomas at injection site due to injection.Additionally information regarding corrective treatment, outcome of the events and human insulin isophane suspension 70%/ human insulin 30% and human insulin treatments status were not provided.The operator of the devices and his/her training status was unknown.The general device duration of use and the suspect device duration of use were not provided.The action taken with the suspect devices was not provided and its return was not expected.There is evidence of improper use.The patient reused needles.The reporting consumer did not provide an assessment of relatedness between the events and human insulin isophane suspension 70%/ human insulin 30%, human insulin or to the humapens savvio pink.Update (b)(6) 2016: upon review, this case was opened to update the medwatch and european and canadian required device reporting elements for regulatory reporting.The product complaint numbers were added to the case.Edit (b)(6) 2016: information received from the complaint department on (b)(6) 2016.Product complaint reference numbers were already processed.No adverse event information was received.Update (b)(6) 2016: additional information received on (b)(6) 2016 from global product complaint database updated the lot number from 1309v00 to 1309v06 for product complaint (b)(6).The product tab for humapen savvio and the narrative were updated.Update (b)(6) 2016.Follow up received (b)(6) 2016 from the product complaint safety database.On the device tabs entered the device specific safety summary (dsss), updated the european and canadian (eu/ca) device information, updated the device medwatch information, and the narrative was updated accordingly.

• Brand Name: HUMAPEN SAVVIO 3ML (PINK)
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer (Section G): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer Contact: caroline rosewell ; lilly corporate center; indianapolis, IN 46285 ; 3172764376
• MDR Report Key: 6147369
• MDR Text Key: 61517246
• Report Number: 1819470-2016-00308
• 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,consum
• Type of Report: Initial
• Report Date: 11/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MS9697
• Device Lot Number: 1309V06
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2016
• 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 HUMAN
• Patient Outcome(s): Other
• Patient Age: 24 YR
• Patient Weight: 83