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

Model Number MS9697

Device Problems Break (1069); Failure to Deliver (2338); Mechanical Jam (2983)

Patient Problems Hyperglycemia (1905); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by consumer who contacted the company to report adverse events and a product complaint (pc) with additional information from pharmacist, concerned a female patient of unknown age and ethnicity.Medical history and concomitant medications were not provided.The patient began taking insulin lispro (rdna origin) injections (humalog, 100u/ml) from cartridge via a reusable pen (humapen savvio, pink), subcutaneously, for diabetes mellitus (dm) (dose and frequency were not provided), beginning on an unspecified date.On an unknown date, while being on insulin lispro therapy, she had a circulatory collapse and her blood glucose was out of control (values, units and normal reference range not provided) for which she had been hospitalized on (b)(6) 2020 (reported as during the last weekend).On an unknown date, she noticed that her humapen savvio (pink) device was broken as the injection screw did not come out and the humapen savvio (pink) did not release insulin lispro (pc no.(b)(4), lot no.1405v02).Further information regarding corrective treatment was not provided.She got recovered from the event of circulatory collapse while the outcome for remaining event was not reported.Status of insulin lispro therapy was not provided.Follow up would not be possible as the reporter denied consent and the treating physician contact details were not provided.The operator of the humapen savvio (pink) and his/her training status was not provided.The general humapen savvio (pink) model duration of use and the suspect humapen savvio (pink) model duration of use were not provided.The action taken with the humapen savvio (pink) was not provided and its return was expected.The reporting consumer and pharmacist did not provide any relatedness assessment for the events with insulin lispro therapy and humapen savvio (pink) device.Update 14-aug-2020: information received on 12-aug-2020 and 14-aug-2020 was combined and processed together.Update 24-aug-2020: additional information was received from pharmacist reporter on 21-aug-2020.Added pharmacist reporter.Updated the suspect drug coding to insulin lispro cartridges, product delivered by device and as reported causality for the event of blood glucose abnormal with the suspect humapen savvio (pink) device.Upon review of the case, updated the indication for use to diabetes mellitus.Updated the causality statement and narrative with new information.Edit 27aug2020: updated medwatch european and (b)(6) fields for expedited device reporting.No new information added.

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 06oct2020 in the b.5.Field.No further follow up is planned.Evaluation summary: a female patient reported that the injection screw of her humapen savvio device did not come out, and the device did not release insulin.She experienced abnormal blood glucose.Investigation of the returned device (batch 1405v02, manufactured may 2014) found the device met functional requirements and met dose accuracy and glide (injection) force specifications.No malfunction was identified.A complaint history review of the batch did not identify any atypical findings with respect to device not working issues.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 case, reported by consumer who contacted the company to report adverse events and a product complaint (pc) with additional information from pharmacist, concerned a female patient of unknown age and ethnicity.Medical history and concomitant medications were not provided.The patient began taking insulin lispro (rdna origin) injections (humalog, 100u/ml) from cartridge via a reusable pen (humapen savvio, pink), subcutaneously, for diabetes mellitus (dm) (dose and frequency were not provided), beginning on an unspecified date.On an unknown date, while being on insulin lispro therapy, she had a circulatory collapse and her blood glucose was out of control (values, units and normal reference range not provided) for which she had been hospitalized on (b)(6)2020 (reported as during the last weekend).On an unknown date, she noticed that her humapen savvio (pink) device was broken as the injection screw did not come out and the humapen savvio (pink) did not release insulin lispro ((b)(4), lot no.1405v02).Further information regarding corrective treatment was not provided.She got recovered from the event of circulatory collapse while the outcome for remaining event was not reported.Status of insulin lispro therapy was not provided.Follow up would not be possible as the reporter denied consent and the treating physician contact details were not provided.The operator of the humapen savvio (pink) and his/her training status was not provided.The general humapen savvio (pink) model duration of use and the suspect humapen savvio (pink) model duration of use were not provided.The action taken with the humapen savvio (pink) was not provided and it was returned to the manufacturer on 24aug2020.The reporting consumer and pharmacist did not provide any relatedness assessment for the events with insulin lispro therapy and humapen savvio (pink) device.Update 14-aug-2020: information received on 12-aug-2020 and 14-aug-2020 was combined and processed together.Update 24-aug-2020: additional information was received from pharmacist reporter on 21-aug-2020.Added pharmacist reporter.Updated the suspect drug coding to insulin lispro cartridges, product delivered by device and as reported causality for the event of blood glucose abnormal with the suspect humapen savvio (pink) device.Upon review of the case, updated the indication for use to diabetes mellitus.Updated the causality statement and narrative with new information.Edit 27aug2020: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 06oct2020: additional information received on 05oct2020 from the global product complaint database.Entered the device specific safety summary (dsss).Updated the medwatch and european and canadian (eu/ca) device fields, malfunction from unknown to no, and device return status to returned to manufacturer.Added the date of manufacture and date returned to manufacturer for the suspect device associated with (b)(4).Corresponding fields and narrative 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
• MDR Report Key: 10460463
• MDR Text Key: 213220972
• Report Number: 1819470-2020-00107
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9697
• Device Lot Number: 1405V02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Initial Date Manufacturer Received: 08/12/2020
• Initial Date FDA Received: 08/27/2020
• Supplement Dates Manufacturer Received: 10/05/2020
• Supplement Dates FDA Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization