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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN SAVVIO 3ML (RED); FOR TREATMENT PURPOSES
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ELI LILLY AND COMPANY HUMAPEN SAVVIO 3ML (RED); FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9694
Device Problem Mechanical Jam (2983)
Patient Problems Edema (1820); Hearing Impairment (1881); Hyperglycemia (1905); Hypoglycemia (1912); Pain (1994); Diabetic Ketoacidosis (2364)
Event Date 10/31/2019
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: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerns a (b)(6) year-old female patient of an unspecified origin.Medical history included macular edema and eye laser surgery for the macular edema.Concomitant medications included insulin glargine for diabetes mellitus.The patient received insulin lispro (rdna origin) injection (humalog 100u/ml) solution via a reusable device (humapen savvio red), 10 iu (international units) in the morning, 12 iu mid-day and 8 iu at night, subcutaneously, for the treatment of diabetes mellitus beginning in 2015.On an unspecified date, unknown time after staring insulin lispro, she felt that she had hypoglycemia but when she measured her blood glucose level, it was 134 mg/dl.No baseline results were provided.On an unspecified date, she recovered from this event of blood sugar abnormal.Approximately, since 2018 she was experiencing difficulty in hearing due to aging.Approximately, since 2018 or 2019 she was experiencing recurrent macular edema and she was receiving unspecified injection sessions as treatment (further information was not provided).The company considered the event of recurrent macular edema as serious due to its medical significance.In (b)(6) 2019, she experienced high blood glucose levels; her blood glucose level reached 300 mg/dl and her glycosylated hemoglobin (hba1c) reached 7.7% (baselines results were not provided), so she was hospitalized.After being hospitalized, she was diagnosed with diabetic ketoacidosis associated to the high blood glucose and received unspecified intravenous solutions as treatment.She was hospitalized for four days; hospitalization dates were not provided.In (b)(6) 2019, she fully recovered from the high blood glucose levels associated with diabetic ketoacidosis.Approximately late (b)(6) 2019 her humapen savvio red was stuck, she adjusted the dose and pushed the injection button but no insulin came out from the humapen savvio red despite replacing the needle as the screw got stuck and the patient could not push it (pc: (b)(4)/ lot: 1304v03).Reportedly, she did not miss her doses as she used an insulin syringe to give her dose, however, because of the difficulty in her vision related to her macular edema she thought that taking the doses with the humapen savvio red would be more accurate.No inaccurate dose reported.Furthermore, approximately late (b)(6) 2019 she was suffering from thumb pain due to pushing the humapen savvio red injection button that had been stuck for two weeks.Outcome of the event of hba1c reached 7.7% was not provided.She did not recover from the remaining events.Information regarding additional corrective treatment was not provided.Insulin lispro treatment was ongoing.The user of the humapen savvio red was the patient and her training status was not provided.The general humapen savvio red model duration of use was not provided and the duration of use of the humapen savvio red considered as suspect was approximately five years as it was started in 2015.The patient stopped using the humapen savvio red late (b)(6) 2019, it was unknown if the humapen savvio would be returned.The reporting consumer did not know if the event of recurrent macular edema was related to the treatment with insulin lispro, did not relate the events of difficulty in hearing and thumb pain to the treatment with insulin lispro, and did not provide any other opinion of causality between remaining events and insulin lispro treatment.The reporting consumer related the event of thumb pain to the humapen savvio red, did not relate the event of difficulty in hearing to the humapen savvio red, and did not provide any other opinion of causality between events and the humapen savvio red.The reporting consumer assessed the event of difficulty in hearing to her age.Edit 03-feb-2020: pc (b)(4) received, processed and added to the narrative.Edit 04feb2020: updated medwatch and european and (b)(6) (eu/(b)(6)) fields for expedited device reporting.No new information added.
 
Event Description
Lilly case id: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerns a 67-year-old female patient of an unspecified origin.Medical history included macular edema and eye laser surgery for the macular edema.Concomitant medications included insulin glargine for diabetes mellitus.The patient received insulin lispro (rdna origin) injection (humalog 100u/ml) solution via a reusable device (humapen savvio red), 10 iu (international units) in the morning, 12 iu mid-day and 8 iu at night, subcutaneously, for the treatment of diabetes mellitus beginning in 2015.On an unspecified date, unknown time after staring insulin lispro, she felt that she had hypoglycemia but when she measured her blood glucose level, it was 134 mg/dl.No baseline results were provided.On an unspecified date, she recovered from this event of blood sugar abnormal.Approximately, since 2018 she was experiencing difficulty in hearing due to aging.Approximately, since 2018 or 2019 she was experiencing recurrent macular edema and she was receiving unspecified injection sessions as treatment (further information was not provided).The company considered the event of recurrent macular edema as serious due to its medical significance.In (b)(6)2019, she experienced high blood glucose levels; her blood glucose level reached 300 mg/dl and her glycosylated hemoglobin (hba1c) reached 7.7% (baselines results were not provided), so she was hospitalized.After being hospitalized, she was diagnosed with diabetic ketoacidosis associated to the high blood glucose and received unspecified intravenous solutions as treatment.She was hospitalized for four days; hospitalization dates were not provided.In (b)(6)2019, she fully recovered from the high blood glucose levels associated with diabetic ketoacidosis.Approximately late (b)(6)2019 her humapen savvio red was stuck, she adjusted the dose and pushed the injection button but no insulin came out from the humapen savvio red despite replacing the needle as the screw got stuck and the patient could not push it ((b)(4)/ lot number 1304v03).Reportedly, she did not miss her doses as she used an insulin syringe to give her dose, however, because of the difficulty in her vision related to her macular edema she thought that taking the doses with the humapen savvio red would be more accurate.No inaccurate dose reported.Furthermore, approximately late (b)(6)2019 she was suffering from thumb pain due to pushing the humapen savvio red injection button that had been stuck for two weeks.Outcome of the event of hba1c reached 7.7% was not provided.She did not recover from the remaining events.Information regarding additional corrective treatment was not provided.Insulin lispro treatment was ongoing.The user of the humapen savvio red was the patient and her training status was not provided.The general humapen savvio red model duration of use was not provided and the duration of use of the humapen savvio red considered as suspect was approximately five years as it was started in 2015.The patient stopped using the humapen savvio red late (b)(6)2019.The suspect humapen savvio (red) device associated with product complaint (b)(4) was not returned to the manufacturer.The reporting consumer did not know if the event of recurrent macular edema was related to the treatment with insulin lispro, did not relate the events of difficulty in hearing and thumb pain to the treatment with insulin lispro, and did not provide any other opinion of causality between remaining events and insulin lispro treatment.The reporting consumer related the event of thumb pain to the humapen savvio red, did not relate the event of difficulty in hearing to the humapen savvio red, and did not provide any other opinion of causality between events and the humapen savvio red.The reporting consumer assessed the event of difficulty in hearing to her age.Edit 03-feb-2020: (b)(4) received, processed and added to the narrative.Edit 04feb2020: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 11feb2020: additional information received on 10feb2020 and further information also received on 10feb2020 from the global product complaint database, which was processed together.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 suspect humapen savvio (red) device associated with product complaint (b)(4), which was not returned 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 11feb2020 in the b.5.Field.No further follow-up is planned.Evaluation summary: a female patient reported that in (b)(6) 2019 her humapen savvio device was stuck.She adjusted the dose and pushed the injection button, but no insulin came out despite replacing the needle as the screw got stuck and the patient could not push it.In addition, the patient reported that she has vision difficulty.In (b)(6) 2019, she experienced diabetic ketoacidosis.The device was not returned to the manufacturer for investigation (batch 1304v03, manufactured april 2013).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review of the batch did not identify any atypical findings with respect to pen jammed.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 user manual states the humapen savvio device is not recommended for the blind or 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 is relevant to the event of diabetic ketoacidosis.
 
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Brand Name
HUMAPEN SAVVIO 3ML (RED)
Type of Device
FOR TREATMENT PURPOSES
Manufacturer (Section D)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis IN 46285
MDR Report Key9676107
MDR Text Key188048405
Report Number1819470-2020-00011
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K160668
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 02/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberMS9694
Device Lot Number1304V03
Was Device Available for Evaluation? No
Date Manufacturer Received02/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age67 YR
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