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

Model Number MS9695

Device Problems Inaccurate Delivery (2339); Mechanics Altered (2984); Insufficient Information (3190)

Patient Problem Hyperglycemia (1905)

Event Date 05/16/2023

Event Type  Injury  

Event Description

Lilly case id: (b)(6).This report is associated with product complaint: (b)(4).This regulatory authority case, reported by pharmacist via regulatory agency, to report adverse events and a product complaint (pc), with additional information from an additional pharmacist, concerned an 80-year-old (at the time of the initial report) male patient of unknown ethnicity.Medical history included type 2 diabetes, hypertension, and increased cholesterol values.Concomitant medications included insulin glargine, hydrochlorothiazide and ramipril for unknown indication.The patient received insulin lispro (rdna origin) injections (humalog) via cartridge with humapen savvio blue, subcutaneously, for the treatment of type 2 diabetes.Dose, frequency, and therapy start date were not provided.On (b)(6) 2023, while on insulin lispro therapy, he experienced difficulties with his humapen savvio blue.He noticed that the plunger of the ampoule does not move evenly and completely when insulin is delivered (lot number 2101s01/ pc (b)(4)).Therefore, he had an inaccurate dosage and he experienced blood sugar fluctuations up to uncontrollable high values (no values reported).The event of increased blood glucose was considered serious for medical significance by the company.He was not hospitalized because of the high blood sugar levels.In addition, it was noted by the pharmacist that the pen needs to be primed more often than after inserting a new cartridge (considered improper use).Information regarding outcome of the events, corrective treatment and insulin lispro therapy status was not reported.The operator of the humapen savvio blue was the patient and his training status was not provided.The general humapen savvio blue model duration of use was not provided.The suspect humapen savvio blue duration of use was five months.It was unknown if the suspect humapen savvio blue was available for its return and would be evaluated if returned.The reporting pharmacist did not provide an opinion of relatedness between the events and insulin lispro therapy or the humapen savvio blue.Edit (b)(6) 2023: upon internal review of information received on (b)(6) 2023, updated seriousness of the case from non-serious to serious and upgraded event of blood glucose increased to serious for medical significance.Added humapen savvio euca fields.Updated narrative accordingly.Edit (b)(6) 2023: upon external review of initial information received on (b)(6) 2023, narrative was updated to reflect that seriousness assessment was provided by company and not by the regulator.Edit (b)(6) 2023: upon internal review of information received on (b)(6) 2023, the improper use and storage was updated from no to yes.Updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.

Manufacturer Narrative

Since the device is not being returned, evaluation for a malfunction is not possible.A follow-up report will be submitted when the final evaluation is completed, as necessary.

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(s) dated 22jun2023 in the b.5.Field.No further follow-up is planned.Evaluation summary a pharmacist reported on behalf of a male patient that the plunger of the patient's humapen savvio device does not move evenly and completely when insulin is delivered; therefore, he had an inaccurate dosage.The patient experienced increased blood glucose levels.Investigation of the returned device (batch 2101s01, manufactured january 2021) found the device met functional requirements and met dose accuracy and glide (injection) force specifications.No malfunction was identified.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 regulatory authority case, reported by pharmacist via regulatory agency, to report adverse events and a product complaint (pc), with additional information from an additional pharmacist, concerned an 80-year-old (at the time of the initial report) male patient of unknown ethnicity.Medical history included type 2 diabetes, hypertension, and increased cholesterol values.Concomitant medications included insulin glargine, hydrochlorothiazide and ramipril for unknown indication.The patient received insulin lispro (rdna origin) injections (humalog) via cartridge with humapen savvio blue, subcutaneously, for the treatment of type 2 diabetes.Dose, frequency, and therapy start date were not provided.On (b)(6) 2023, while on insulin lispro therapy, he experienced difficulties with his humapen savvio blue.He noticed that the plunger of the ampoule does not move evenly and completely when insulin is delivered (lot number 2101s01/(b)(4)).Therefore, he had an inaccurate dosage and he experienced blood sugar fluctuations up to uncontrollable high values (no values reported).The event of increased blood glucose was considered serious for medical significance by the company.He was not hospitalized because of the high blood sugar levels.In addition, it was noted by the pharmacist that the pen needs to be primed more often than after inserting a new cartridge.Information regarding outcome of the events, corrective treatment and insulin lispro therapy status was not reported.The operator of the humapen savvio blue was the patient and his training status was not provided.The general humapen savvio blue model duration of use was not provided.The suspect humapen savvio blue duration of use was five months.The suspect humapen savvio blue was returned to manufacturer.The reporting pharmacist did not provide an opinion of relatedness between the events and insulin lispro therapy or the humapen savvio blue.Edit 26-may-2023: upon internal review of information received on 22-may-2023, updated seriousness of the case from non-serious to serious and upgraded event of blood glucose increased to serious for medical significance.Added humapen savvio euca fields.Updated narrative accordingly.Edit 30-may-2023: upon external review of initial information received on 22-may-2023, narrative was updated to reflect that seriousness assessment was provided by company and not by the regulator.Edit 05may2023: upon internal review of information received on 22may2023, the improper use and storage was updated from no to yes.Updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.Update 22jun2023: additional information received on 21jun2023 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information for (b)(4) associated with lot number 2101s01 of humapen savvio.Updated malfunction from unknown to no, improper use or storage from yes to no, date of manufacturer, device return status to returned to manufacturer, and date returned to manufacturer for the device.Corresponding fields and narrative updated accordingly.

• Brand Name: HUMAPEN SAVVIO 3ML (BLUE)
• 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: 17087194
• MDR Text Key: 316941383
• Report Number: 1819470-2023-00043
• 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: Other,Foreign,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 07/13/2023

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: MS9695
• Device Lot Number: 2101S01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2023
• Initial Date FDA Received: 06/08/2023
• Supplement Dates Manufacturer Received: 06/21/2023
• Supplement Dates FDA Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2021
• 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): Other
• Patient Age: 80 YR
• Patient Sex: Male