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

Model Number MS9698

Device Problems Improper or Incorrect Procedure or Method (2017); Physical Resistance/Sticking (4012)

Patient Problems Abdominal Pain (1685); Hyperglycemia (1905); Pain (1994); Numbness (2415); Weight Changes (2607)

Event Type  malfunction  

Manufacturer Narrative

Reportable malfunction/incident identified.Investigation in progress.A follow-up report will be submitted when the final evaluation is completed as necessary.

Event Description

Lilly case id: (b)(6).This report is associated with product compliant: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned an approximately (b)(6) year old female patient of unknown origin.Medical history and concomitant medications were not provided.The patient received human insulin isophane suspension 70%/ human insulin 30% (rdna origin) injections (humulin 70/30) via reusable humapen savvio (graphite) pen.Dosage regimen, route of administration, indication for use and start date were not reported.Since unknown date, patient was not taking her human insulin 70/30, she frequently skipped her dose and only took it when she was very tired.Additionally, the blood glucose level of her mother was always in range of 500mg/dl.She was eating the wrong diet, loose a lot of weight (current weight (b)(6) kg), experienced abdomen pain and she was also suffering from leg and right hand pain and numbness.On unknown date, her humapen savvio (graphite) pen was put in the freezer and when it was taken out the dose knob became very stiff, it hardly rotated, it was very difficult to press on the dose knob (lot 1305v06/product complaint (b)(4)).Information regarding corrective treatment, outcome for the events and human insulin isophane suspension 70/30 treatment status was not provided.The user of the humapen savvio graphite was unknown and his/her training status was not provided.The humapen savvio graphite model duration of use and the suspect humapen savvio graphite duration of use were not provided.The humapen savvio graphite was returned to the manufacturer on 17jul2019.The reporting consumer did not provide an opinion of relatedness between the events and human insulin isophane suspension 70/30 or to the humapen savvio.Update 13aug2019: additional information received on 17jul2019 from global product complaint database.Processed (b)(4) accordingly.Updated the medwatch fields/ european and canadian (eu/ca) device information and the humapen savvio (graphite) device to malfunction yes/cirm for product complaint (b)(4) and preliminary comments, priority changed as a result.Added date of return to the 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 22aug2019 in the b.5.Field.No further follow-up is planned.Evaluation summary: the daughter of a female patient reported that the patient's humapen savvio device was put in the freezer.When it was taken out, "the dose knob became very stiff, it hardly rotated, it was very difficult to press on the dose knob." investigation of the returned device (batch: 1305v06, manufactured may 2013) found multiple internal components damaged which rendered the device inoperable.The investigation determined this case was associated with the reportable malfunction "clicker clip/sleeve engagement failure." malfunction confirmed.The damage observed to the clicker clip sleeve snaps and sleeve tab slots indicates the device was assembled correctly during manufacturing, and the disengagement of the sleeve from the clicker clip occurred in the field due to excessive force applied to the device.If the clicker clip and sleeve are not engaged properly, the device has the potential for underdoses of up to 100% (maximum underdose (b)(4) units).A complaint history review of this batch found this is the first occurrence for the complaint issue of clicker clip/sleeve engagement failure.All humapen savvio devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality with high probability.The core instructions for use state to not use the device if it appears broken or damaged and to contact lilly or a healthcare professional for a replacement pen.The user manual also provides care and storage directions.There is evidence of improper use.The damage to the device occurred while in the field (not related to the manufacturing process).In addition, the user stored the device in the freezer and applied excessive force to the device.

Event Description

Lilly case id: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned an approximately 44-year old female patient of unknown origin.Medical history and concomitant medications were not provided.The patient received human insulin isophane suspension 70%/ human insulin 30% (rdna origin) injections (humulin 70/30) via reusable humapen savvio (graphite) pen.Dosage regimen, route of administration, indication for use and start date were not reported.Since unknown date, patient was not taking her human insulin 70/30, she frequently skipped her dose and only took it when she was very tired.Additionally, the blood glucose level of her mother was always in range of 500mg/dl.She was eating the wrong diet, loose a lot of weight (current weight 50 kg), experienced abdomen pain and she was also suffering from leg and right hand pain and numbness.On unknown date, her humapen savvio (graphite) pen was put in the freezer and when it was taken out the dose knob became very stiff, it hardly rotated, it was very difficult to press on the dose knob (product complaint: (b)(4)/lot: 1305v06).Information regarding corrective treatment, outcome for the events and human insulin isophane suspension 70/30 treatment status was not provided.The user of the humapen savvio graphite was unknown and his/her training status was not provided.The humapen savvio graphite model duration of use and the suspect humapen savvio graphite duration of use were not provided.The humapen savvio graphite device associated with product complaint: (b)(4) was returned to the manufacturer on 17jul2019.The reporting consumer did not provide an opinion of relatedness between the events and human insulin isophane suspension 70/30 or to the humapen savvio.Update 13aug2019: additional information received on 17jul2019 from global product complaint database.Processed (b)(4) accordingly.Updated the medwatch fields/ european and canadian (eu/ca) device information and the humapen savvio (graphite) device to malfunction yes/cirm for product complaint: (b)(4) and preliminary comments, priority changed as a result.Added date of return to the manufacturer.Corresponding fields and narrative updated accordingly.Update 22aug2019: additional information received on 22aug2019 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information and the european and canadian (eu/ca) device information.Added date of manufacturer for the returned suspect humapen savvio (graphite) device associated with product complaint: (b)(4).Corresponding fields and narrative updated accordingly.

• Brand Name: HUMAPEN SAVVIO 3ML (GRAPHITE)
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• MDR Report Key: 8894238
• MDR Text Key: 196267881
• Report Number: 1819470-2019-00154
• 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,Followup
• Report Date: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MS9698
• Device Lot Number: 1305V06
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/17/2019
• Initial Date Manufacturer Received: 07/17/2019
• Initial Date FDA Received: 08/14/2019
• Supplement Dates Manufacturer Received: 08/22/2019
• Supplement Dates FDA Received: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 50