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

Model Number MS9698

Device Problems Insufficient Flow or Under Infusion (2182); Improper Flow or Infusion (2954); Mechanics Altered (2984); Audible Prompt/Feedback Problem (4020)

Patient Problem Hyperglycemia (1905)

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.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by a consumer, who contacted the company to report adverse events and product complaints (pc), concerned a female patient of unknown age and ethnicity.Medical history and concomitant medications were not provided.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humulin m3), injections, via a cartridge, through a reusable pens (humapen savvio blue 3ml, humapen savvio red 3ml and humapen savvio graphite 3ml).Dose, frequency, route of administration, indication for use and therapy start date were not provided.Since an unspecified date, unknown time after start human insulin isophane suspension 70%/human insulin 30%, she experienced every time her son used the humapen savvio blue 3ml and injected her, the humapen savvio blue 3ml clicked and then the first 2 u seemed to slip, and then the rest of the dose was fine; her son primed reusable pens each time and during priming there was no slipping, her son always used new needles, but since the first 2 u slipped away and possibly were not injected so it was unsure if she had received her full dose (pc 6098219/lot number 2101s01).She also experienced same issue which occurred sometimes with humapen savvio red 3ml (pc 6098220/lot number 2102s01).She experienced same issue with humapen savvio graphite 3ml (pc 6098221/lot number 1912s01); approximately in (b)(6) 2022, she was hospitalized due to high blood sugar (results, units and reference values were not provided), she remained in hospital for 5 days.While hospitalized her blood sugar increased and the hospital stated that humapen savvio graphite 3ml was faulty, but her son believed that the humapan savvio graphite 3ml was fine, but the hospital had not primed it properly before use.Information regarding corrective treatment, outcome the events, laboratory examination findings, hospitalization dates and human insulin isophane suspension 70%/human insulin 30% therapy status was not provided.The son of the patient was the operator of the humapen savvio blue 3ml, humapen savvio red 3ml and humapen savvio graphite 3ml, and his training status was not provided.The suspects humapen savvio blue 3ml, humapen savvio red 3ml and humapen savvio graphite 3ml general model duration of use and the suspects humapen savvio blue 3ml, humapen savvio red 3ml and humapen savvio graphite 3ml duration of use were not provided.Also, the hospital was the operator of the humapen savio graphite 3ml and their training status was unknown.The suspects humapen savvio blue 3ml, humapen savvio red 3ml and humapen savvio graphite 3ml were available for their return; if device is returned, evaluation will be performed to determine if a malfunction has occurred.The reporting consumer did not provide a relatedness assessment between events and the human insulin isophane suspension 70%/human insulin 30% therapy neither to the humapen savvio blue 3ml, humapen savvio red 3ml and humapen savvio graphite 3ml devices.Edit 08sep2022: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.

Event Description

Lilly case id: (b)(4) this report is associated with product complaint: (b)(4) this spontaneous case, reported by a consumer, who contacted the company to report adverse events and product complaints (pc), concerned a female patient of unknown age and ethnicity.Medical history and concomitant medications were not provided.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humulin m3), injections, via a cartridge, through a reusable pens (humapen savvio blue 3ml, humapen savvio red 3ml and humapen savvio graphite 3ml).Dose, frequency, route of administration, indication for use and therapy start date were not provided.Since an unspecified date, unknown time after start human insulin isophane suspension 70%/human insulin 30%, she experienced every time her son used the humapen savvio blue 3ml and injected her, the humapen savvio blue 3ml clicked and then the first 2 u seemed to slip, and then the rest of the dose was fine; her son primed reusable pens each time and during priming there was no slipping, her son always used new needles, but since the first 2 u slipped away and possibly were not injected so it was unsure if she had received her full dose ((b)(4)/lot number 2101s01).She also experienced same issue which occurred sometimes with humapen savvio red 3ml ((b)(4)/lot number 2102s01).She experienced same issue with humapen savvio graphite 3ml ((b)(4)/lot number 1912s01); approximately in (b)(6) 2022, she was hospitalized due to high blood sugar (results, units and reference values were not provided), she remained in hospital for 5 days.While hospitalized her blood sugar increased and the hospital stated that humapen savvio graphite 3ml was faulty, but her son believed that the humapan savvio graphite 3ml was fine, but the hospital had not primed it properly before use.Information regarding corrective treatment, outcome the events, laboratory examination findings, hospitalization dates and human insulin isophane suspension 70%/human insulin 30% therapy status was not provided.The son of the patient was the operator of the humapen savvio blue 3ml, humapen savvio red 3ml and humapen savvio graphite 3ml, and his training status was not provided.The suspects humapen savvio blue 3ml, humapen savvio red 3ml and humapen savvio graphite 3ml general model duration of use and the suspects humapen savvio blue 3ml, humapen savvio red 3ml and humapen savvio graphite 3ml duration of use were not provided.Also, the hospital was the operator of the humapen savio graphite 3ml and their training status was unknown.The suspects humapen savvio blue 3ml, humapen savvio red 3ml and humapen savvio graphite 3ml were available for their return; if device is returned, evaluation will be performed to determine if a malfunction has occurred.The reporting consumer did not provide a relatedness assessment between events and the human insulin isophane suspension 70%/human insulin 30% therapy neither to the humapen savvio blue 3ml, humapen savvio red 3ml and humapen savvio graphite 3ml devices.Edit 08sep2022: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 04oct2022: additional information received on 29sep2022 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 1912s01 of humapen savvio (graphite).Updated improper use and storage from yes to no and date of 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 (s) dated 04oct2022 in the b.5.Field.No further follow-up is planned evaluation summary the patient's son reported the humapen savvio device "clicks" when he injects the dose.He also stated, "the first 2 units seem to slip, and then the rest of the dose is fine," and he was unsure his mother received her full dose.The patient experienced increased blood glucose.The device was not returned to the manufacturer for investigation (batch 1912s01, manufactured december 2019).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review did not identify any atypical findings with regards to device not working or dose accuracy issues.All humapen 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.There is no evidence of improper use or storage.

• 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
• 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: 15391460
• MDR Text Key: 299599068
• Report Number: 1819470-2022-00069
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K160668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9698
• Device Lot Number: 1912S01
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2019
• 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