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

Model Number MS9694

Device Problems Mechanical Problem (1384); Failure to Deliver (2338); Mechanics Altered (2984); Output Problem (3005)

Patient Problem Hyperglycemia (1905)

Event Date 05/11/2021

Event Type  Injury  

Manufacturer Narrative

If device is returned, evaluation will be performed to determine if a malfunction has occurred.This is an initial report.A follow-up report will be submitted when the final evaluation is completed.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by a nurse, concerns a patient of unknown age, gender and ethnicity.Information regarding medical history and concomitant medication was not provided.The patient received an unspecified insulin via humapen savvio red at unknown dose, frequency, route of administration, indication for use and start date.On unspecified date, unknown time after starting humapen savvio red, the patient experienced hyperglycemia despite high dose of insulin, which reportedly required hospitalization, but it was unclear if caused or prolonged an existing hospitalization.The reporting nurse checked the patients therapy and stated the humapen savvio red (lot c926392) was not working as usual, when the button was pressed, it did not feel the thrust was regular.It was reported that the humapen savvio red did not have any visible damage outside, but when the nurse tired to give insulin to the patient, it definitely did not inject trough needle (which they changed, also insulin ampoule).Information regarding corrective treatment, laboratory exams and outcome of event was not provided.It was unknown if treatment with unspecified insulin was continued.It was unknown who operated the device and if the operator was trained.Duration of use of this device model and the reported device were unknown.Status of device was not provided, but its return was expected.The reporting nurse was not sure if hyperglycemia was related to the humapen savvio red.Edit 26 may 2021: no new information added.Edit 08 jun 2021: upon internal review on 08 jun 2021, it was noticed the device had been identified as humapen savvio red, therefore device was updated from unknown color to red.

Manufacturer Narrative

B.5.Narrative field; new updated and corrected information is referenced within the update statements in b.5.Please refer to statement dated 21jun2021 in the b.5.Field.No further follow up is planned.Evaluation summary: a nurse reported on behalf of a patient reported that when the injection button of the patient's humapen savvio device was pressed, "it did not feel the thrust was regular." the nurse reported the insulin did not inject.The patient experienced hyperglycemia.The device was not returned to the manufacturer for investigation (batch 1507v03, manufactured july 2015).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review did not identify any atypical findings with regard to device not working issues.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 complaint: (b)(4).This spontaneous device case, reported by a nurse, with additional information from the initial reporter in response to a medical questionnaire, concerns a middle aged, caucasian male patient of unspecified age.Medical history included type 2 diabetes mellitus.Information regarding concomitant medication was not provided.The patient received insulin human (humulin r) unknown formulation, 12 iu three times a day; route of administration, indication for use and start date were not provided, via humapen savvio (red).Between (b)(6) 2021 and (b)(6) 2021, unknown time after starting insulin human treatment, the patient experienced hyperglycemia despite high dose of insulin, which reportedly was not admitted due to this to the hospital, but it was unclear if it prolonged an existing hospitalization.The reporting nurse checked the patients therapy and stated the humapen savvio (red) was not working as usual, when the button was pressed, it did not feel the thrust was regular.It was reported that the humapen savvio (red) did not have any visible damage outside, but when the nurse tired to give insulin to the patient, it definitely did not inject through needle (which they changed, also insulin ampoule).(pc (b)(4); lot 1507v03) information regarding corrective treatment, laboratory exams and outcome of event was not provided.It was unknown if treatment with unspecified insulin was continued.The nurse was the operator of the device and she was trained.Duration of use of this device model and the reported device was maximum six years.Status of device was not provided.The device was not returned to the manufacturer.The reporting nurse was not sure if hyperglycemia was related to the humapen savvio (red).Edit 26may2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 08jun2021: upon internal review on 08jun2021, it was noticed the device had been identified as humapen savvio red, therefore device was updated from unknown color to red.Narrative and corresponding fields were updated accordingly.Update 14jun2021: additional information received on 11jun2021 from global product complaint database.Updated lot number from c926392 to 1507v03 for product complaint 5587760 relating to the suspect humapen savvio (red).Corresponding fields and narrative updated accordingly.Update 21jun2021: additional information received on 15jun2021 from the global product complaint database.Entered the device specific safety summary (dsss); updated the medwatch and european and canadian (eu/ca) device fields; added the date of manufacture for the suspect device associated with pc (b)(4).Corresponding fields and narrative updated accordingly.Update 23jun2021: upon review of information received on 15jun2021, added the annex g code in the medwatch fields.Update 09-jul-2021: additional information was received from the initial reporter in response to a medical questionnaire on (b)(6) 2021.Demographics of the patient were updated, medical history, insulin human was added as suspect drug, hospitalization details and device user and age were updated.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
• MDR Report Key: 11966365
• MDR Text Key: 267444040
• Report Number: 1819470-2021-00073
• 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,Followup
• Report Date: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9694
• Device Lot Number: C926392
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization