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

Model Number UNKNOWN

Device Problems Break (1069); Material Separation (1562); Patient Device Interaction Problem (4001)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by a nurse who contacted the company to report adverse events and a product complaint (pc), concerned a female patient of unspecified age and origin.Medical history and concomitant medications were not provided.The patient received insulin lispro (rdna origin) (humalog 100 u/ml) from cartridge via a reusable pen humapen, unknown device, unknown color, at an unknown dose and frequency, subcutaneously, for the treatment of diabetes mellitus beginning on an unknown date.Since an unknown date, while on insulin lispro therapy, her vision aggravated/vision was very bad/could not see very well.Since unknown date, her blood glucose was out of range/blood glucose was abnormal (values, units and reference range were not provided), due to which she was hospitalized on an unknown date.Further hospitalization details were not provided.Additionally reported, in the past she had been able to take care of herself but now she could no longer do so (specific details about particular situation not provided), also before, she injected herself, but then she could not do it anymore.Since hospitalization she was taken care off by nurses.On an unknown date, humapen, broke apart (pc 6003612/ lot unknown).Information regarding corrective treatment was not provided.Outcome of the events was unknown.Status of insulin lispro therapy was unknown.The patient was the operator of the humapen and her training status was not provided.The general humapen duration and the suspect humapen duration of use were not provided.Action taken with suspect humapen was not provided and it was not available for return since discarded.The initial reporting nurse did not provide the opinion of relatedness between the events and insulin lispro therapy and with humapen.Update (b)(6) 2022: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting and added contact log accordingly.No new information added.Edit (b)(6) 2022: upon review of information received on 07-jun-2022, updated suspect device coding from humapen unknown to humapen savvio, unknown color and eu/ca fields, updated narrative accordingly.No other changes were performed to the case.

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 who contacted the company to report adverse events and a product complaint (pc), concerned a female patient of unspecified age and origin.Medical history and concomitant medications were not provided.The patient received insulin lispro (rdna origin) (humalog 100 u/ml) from cartridge via a reusable pen humapen savvio, unknown color, at an unknown dose and frequency, subcutaneously, for the treatment of diabetes mellitus beginning on an unknown date.Since an unknown date, while on insulin lispro therapy, her vision aggravated/vision was very bad/could not see very well/ reduced vision.Since unknown date, her blood glucose was out of range/blood glucose was abnormal/ blood glucose event (values, units and reference range were not provided), due to which she was hospitalized on an unknown date.Further hospitalization details were not provided.Additionally reported, in the past she had been able to take care of herself but now she could no longer do so (specific details about particular situation not provided), also before, she injected herself, but then she could not do it anymore.Since hospitalization she was taken care off by nurses.On an unknown date, humapen savvio, unknown color, broke apart (pc 6003612/ lot unknown).Information regarding corrective treatment was not provided.Outcome of the events was unknown.Status of insulin lispro therapy was unknown.The patient was the operator of the humapen savvio and her training status was not provided.The general humapen savvio duration and the suspect humapen savvio duration of use were not provided.Action taken with suspect humapen savvio was disposed and it was not available for return.The device was not returned to the manufacturer for investigation.The initial reporting nurse did not provide the opinion of relatedness between the events and insulin lispro therapy and with humapen savvio.Update 16jun2022: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting and added contact log accordingly.No new information added.Edit 16-jun-2022: upon review of information received on 07-jun-2022, updated suspect device coding from humapen unknown to humapen savvio, unknown color and eu/ca fields, updated narrative accordingly.No other changes were performed to the case.Update 24-jun-2022: additional information was received from the initial reporting consumer on 22-jun-2022.Updated the description as reported of the events and combo product associated with device field of humapen savvio.Narrative was updated accordingly.Update 27jun2022: additional information received on 21jun2022 from the global product complaint database.Entered device specific safety summary (dsss) for humapen savvio device, unknown colour associated with (b)(4), lot unknown.Updated the medwatch fields/ european and canadian (eu/ca) device information and device return status to not returned to manufacturer.Corresponding fields and narrative updated accordingly.

Manufacturer Narrative

B.5.Narrative field: new, updated and corrected information is referenced within the update statements in b.5.Please refer to update statement dated 27jun2022 in the b.5.Field.No further follow-up is planned.Evaluation summary: a female patient reported that her humapen savvio broke apart.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 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 patient reported visual impairment.The core instructions for use states that the device is not recommended for the visually impaired without the assistance of a sighted individual trained to use it.There is evidence of improper use.The patient used the device while visually impaired.It is unknown if this misuse is relevant to the complaint or the event of abnormal blood glucose.

• Brand Name: HUMAPEN SAVVIO 3ML (UNKNOWN COLOR)
• 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: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 14715982
• MDR Text Key: 294947965
• Report Number: 1819470-2022-00047
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K160668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2022
• 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 Sex: Female