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

Model Number UNKNOWN

Device Problems Material Separation (1562); Insufficient Information (3190)

Patient Problem Hypoglycemia (1912)

Event Date 01/31/2013

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: 6872811 this solicited case, reported by a consumer via a patient support program (psp), concerned an 46-year-old female patient of an unknown origin.Medical history included diabetes mellitus.Concomitant medications were not reported.The patient received human insulin isophane suspension (rdna origin) injection (humulin n) from cartridge via a reusable device, humapen savvio gray, 20 international unit every night, via an unknown route for the treatment of diabetes mellitus, beginning on an unspecified date in 2013.The patient also received insulin lispro (rdna origin) injection (humalog 100units/ml) from cartridge via humapen savvio gray, 44 international unit via an unknown route for the treatment of diabetes mellitus, beginning on an unspecified date in 1989.On an unknown date while on human insulin isophane suspension and insulin lispro therapy she had 200-300 mg/dl (reference range were not provided) glucose measurement due to the humapen savvio device issue as she could not get the correct dose of human insulin isophane suspension (pc number 6872811, lot number 1784v62).She also experienced hypoglycemia having blood glucose value may be 20-30mg/dl (reference range were not provided).She drinks juices and eats chocolates as a corrective treatment for hypoglycemia and administered more insulin for hyperglycemia as corrective treatment.The event of hypoglycemia was considered as serious due to its medically significant reason.The outcome of the events hypoglycemia, hyperglycemia was not recovered while for the remaining event was unknown.The status of human insulin isophane suspension and insulin lispro therapies was continued.The operator of humapen savvio gray was the patient and her training status was not provided.The general and suspect humapen savvio gray device duration of use was not reported.The status of suspect humapen savvio gray was unknown however if the suspect humapen savvio gray device was returned, evaluation would be performed to determine if malfunction had occurred.The reporting consumer related the events of hypoglycemia and hyperglycemia with the human insulin isophane suspension and did not provide any relatedness of the event incorrect dose administered with the human insulin isophane suspension while did not relate it with the suspect humapen savvio device.The reporting consumer did not provide any relatedness of the events with the insulin lispro therapy.Edit 21-dec-2023: upon review of the information on 11-dec-2023, added device paragraph in the narrative.Edit 26-dec-2023: upon review of information on 11-dec-2023.Updated the formulation of humalog from insulin lispro unknown formulation to insulin lispro cartridge.Edit 04jan2024: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.

Event Description

Lilly case id: (b)(6) this report is associated with product complaint: (b)(4) this solicited case, reported by a consumer via a patient support program (psp), concerned an 46-year-old female patient of an unknown origin.Medical history included diabetes mellitus.Concomitant medications were not reported.The patient received human insulin isophane suspension (rdna origin) injection (humulin n) from cartridge via a reusable device, humapen savvio unknown color, 20 international unit every night, via an unknown route for the treatment of diabetes mellitus, beginning on an unspecified date in 2013.The patient also received insulin lispro (rdna origin) injection (humalog 100units/ml) from cartridge via humapen savvio unknown color, 44 international unit via an unknown route for the treatment of diabetes mellitus, beginning on an unspecified date in 1989.On an unknown date while on human insulin isophane suspension and insulin lispro therapy she had 200-300 mg/dl (reference range were not provided) glucose measurement due to the humapen savvio device issue as she could not get the correct dose of human insulin isophane suspension (pc number (b)(4), lot number 1784v62) as device was broken just below where the needle snaps, resulting in the medicine spreads left and right when she goes to administer (considered improper use).She also experienced hypoglycemia having blood glucose value may be 20-30mg/dl (reference range were not provided).She drinks juices and eats chocolates as a corrective treatment for hypoglycemia and administered more insulin for hyperglycemia as corrective treatment.The event of hypoglycemia was considered as serious due to its medically significant reason.The outcome of the events hypoglycemia, hyperglycemia was not recovered while for the remaining event was unknown.The status of human insulin isophane suspension and insulin lispro therapies was continued.The operator of humapen savvio was the patient and her training status was not provided.The general and suspect humapen savvio unknown color device duration of use was not reported.The status of suspect humapen savvio unknown color was unknown.The suspect humapen savvio unknown color device was not returned.The reporting consumer related the events of hypoglycemia and hyperglycemia with the human insulin isophane suspension and did not provide any relatedness of the event incorrect dose administered with the human insulin isophane suspension while did not relate it with the suspect humapen savvio unknown color device.The reporting consumer did not provide any relatedness of the events with the insulin lispro therapy.Edit 21-dec-2023: upon review of the information on 11-dec-2023, added device paragraph in the narrative.Edit 26-dec-2023: upon review of information on 11-dec-2023.Updated the formulation of humalog from insulin lispro unknown formulation to insulin lispro cartridge.Edit 04jan2024: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 17jan2024: upon internal review of information received initially on 11dec2023 and additional information received on 12jan2024 from the global product complaint.Changed suspect humapen savvio (gray) device to suspect huma pen savvio (unknown color).Entered the device specific safety summary (dsss); updated the medwatch device fields; updated improper use or storage from no to yes, updated device was not returned to (b)(4) manufacturer for the suspect humapen savvio 3ml (unknown color) device associated with (.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(s) dated 17jan2024 in the b.5.Field.No further follow-up is planned.Evaluation summary a female patient reported that a piece of her humapen savvio "is broken just below where the needle snaps, resulting in the medicine spreads left and right when she goes to administer.Consequently, the medicine runs out earlier and considering that she does not administer correctly, she measures her glucose after administration and is increased, 200-300mg/dl." she experienced a serious adverse event of hypoglycemia and non-serious adverse events of hyperglycemia and incorrect dose administration.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 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.There is evidence of improper use.The patient used the device while broken.This may be relevant to the non-serious adverse event of hyperglycemia and to the serious adverse event of hypoglycemia if the patient incorrectly adjusted doses and applied additional medication.

• 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): PHILLIPS-MEDISIZE CORPORATION; 415 red cedar street; medical device manufacturing; menomonie WI 54751
• Manufacturer Contact: catherine cassidy ; lilly corporate center; indianapolis 46285 ; 3174332191
• MDR Report Key: 18451785
• MDR Text Key: 332254809
• Report Number: 1819470-2023-00084
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K160668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Device Lot Number: 1784V62/SEEASRPTD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2024
• 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): Other
• Patient Age: 46 YR
• Patient Sex: Female