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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN ERGO II; FOR TREATMENT PURPOSES
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ELI LILLY AND COMPANY HUMAPEN ERGO II; FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9557
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Emotional Changes (1831); High Blood Pressure/ Hypertension (1908); Hypoglycemia (1912); Dizziness (2194); Discomfort (2330); Dyskinesia (2363); Loss of consciousness (2418); Sweating (2444); Palpitations (2467); Shaking/Tremors (2515); No Code Available (3191)
Event Date 11/30/2019
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 compliant: (b)(4).This solicited case reported by a consumer via patient support program (psp), concerned a (b)(6)-year-old (at the time of initial report) (b)(6) female patient (with nationality: (b)(6)).Medical history included heart not good, body not good, blood pressure high; her parents, son and daughter had diabetes.Historical medication included metformin for the treatment of diabetes mellitus type ii and she had stomach discomfort after eating it.Concomitant medication included insulin human, insulin human injection/isophane for treatment of diabetes mellitus, acarbose for the treatment of diabetes mellitus type ii and an antihypertensive drug (unknown name) for the treatment of hypertension.The patient received insulin lispro (rdna origin) (humalog, unspecific type, 100u/ml) from cartridge via a reusable humapen (ergo ii, blue), 18 iu at morning and 18.5 iu at night, two times a day(bid), subcutaneously, for the treatment of diabetes mellitus type ii, beginning on an unknown date(from more than 2 years ago).In addition, she received, insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) (humalog mix 25) unknown formulation, subcutaneously, for the treatment of diabetes mellitus, beginning approximately on an unknown date in jun-2018.Dose and frequency of insulin lispro protamine suspension 75%/insulin lispro 25% therapy was unknown.Sometimes she injected extra units of insulin lispro protamine suspension 75%/insulin lispro 25% therapy (reason unknown).On an unknown date, after 2014, while on insulin lispro therapy, sometimes her blood pressure raised up on four or five o clock in the afternoon in winter.When her blood pressure went high, she took a tablet of unknown antihypertensive drug as a corrective treatment.On an unknown date, she had toothache and face ache.Approximately in (b)(6) 2019, she was hospitalized due to toothache and face ache.On an unknown date, after hospitalization she had trigeminal nerve surgery.After the surgery, she fell unwell about the throat, the voice was uncomfortable, the speech was laborious; half face, tongue and nose were numb; half brain was numb and she was unconscious.It was reported that she did not received any corrective treatment for unconscious.According to her treating physician it was a normal reaction after operation.Her mouth slightly askew/crooked mouth, mouth could not open big and eating was difficult.The events of facial asymmetry, intranasal hypoaesthesia, hypoaesthesia oral, eating disorder, dyskinesia, speech disorder, loss of consciousness, hypoaesthesia, toothache and facial pain were considered serious by the company due to their medical significance.In morning of (b)(6) 2019, her tested blood glucose value was 3.3 (unit and reference range were not provided) and the hypoglycemia occurred (product complaint: 4750464; lot 1508d01).On an unknown date in (b)(6) 2019, conflicting information received, she had hypoglycemia in nights (the blood sugar value was more than 2, no unit was provided).On an unknown dater in (b)(6) 2019, her face was pale, she had sweating, flustered, uncomfortable and hypoglycemia (the blood sugar value was 2.2, no unit was provided).The event of hypoglycemia was considered serious by the company due to its medical significance reason.On an unknown date, she had several uncomfortable feelings and her blood sugar values were 3.8, 3.9 and 4.0 (no unit or reference range was provided).On (b)(6) 2019, she experienced dizziness, panic, heart shaking and sweating and she was recovered from these event on the same day.Information regarding any further corrective treatment and outcome of the events was not provided.Insulin lispro and insulin lispro protamine suspension 75%/insulin lispro 25% therapy were ongoing.The patient was the operator of humapen and her training status was not provided.The general humapen model duration of use was not provided.The suspect humapen duration of use was approximately two years (since the suspect device was started in 2017).The action taken with the suspect humapen was unknown and its return was not provided.The reporting consumer did not provide an assessment of relatedness between the events and insulin lispro drug or humapen.However, the reporting consumer thought the elevated blood pressure was related to the weather and her mood undulated/emotion.The reporting consumer did not relate the events of serious and non serious episodes of hypoglycemia with insulin lispro protamine suspension 75%/insulin lispro 25% therapy whereas did not provide an opinion of relatedness with remaining events.Update on 02-jun-2019: additional information was received from initial reporting consumer via a psp on 24-may-2019 and on 30-may-2019 was processed together.Added: corrective treatment of serious event of unconscious from unknown to no.Updated: as reported verbatim of event facial asymmetry.Narrative was updated with new information accordingly.Update on 30-dec-2019: additional information was received from initial reporting consumer via a psp on 25-dec-2019 and a correction on 25-dec-2019 was processed together.Added blood sugar laboratory values.And one concomitant medication.Added one new suspect drug insulin lispro protamine suspension 75%/insulin lispro 25% and one serious event of hypoglycemia.Updated frequency of non serious event of hypoglycemia as intermittent.Narrative was updated with new information accordingly.Edit on 14-jan-2020: upon review of the information received on 22-may-2019, suspect device age was added in product tab (and narrative) as well as the product complaint and lot number citation was also included in the narrative.No other changes were done into the case.Edit on 14jan2020: updated medwatch fields for expedited device reporting.No new information added.
 
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 28jan2020 in the b.5.Field.No further follow-up is planned.Evaluation summary: a female patient reported that her humapen ergo ii device was dropped and the pen cap cracked.The crack got bigger, and the patient worried the crack would expose the cartridge and affect the normal use of the device.The patient experienced hypoglycemia.The device was not returned to the manufacturer for investigation (batch 1508d01, manufactured august 2015).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 dose accuracy issues.All humapen ergo ii 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 states if any of the parts of your humapen ergo ii appear broken or damaged, do not use.However, a cracked pen cap is not likely to affect the accuracy of the device unless the device itself was damaged when dropped.There is no evidence of improper use or storage.
 
Event Description
Lilly case id: (b)(4).This solicited case reported by a consumer via patient support program (psp), concerned a 76-year-old (at the time of initial report) asian female patient (with nationality: han).Medical history included heart not good, body not good, blood pressure high; her parents, son and daughter had diabetes.Historical medication included metformin for the treatment of diabetes mellitus type ii and she had stomach discomfort after eating it.Concomitant medication included insulin human, insulin human injection/isophane for treatment of diabetes mellitus, acarbose for the treatment of diabetes mellitus type ii and an antihypertensive drug (unknown name) for the treatment of hypertension.The patient received insulin lispro (rdna origin) (humalog, unspecific type, 100u/ml) from cartridge via a reusable humapen (ergo ii, blue), 18 iu at morning and 18.5 iu at night, two times a day(bid), subcutaneously, for the treatment of diabetes mellitus type ii, beginning on an unknown date(from more than 2 years ago).In addition, she received, insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) (humalog mix 25) unknown formulation, subcutaneously, for the treatment of diabetes mellitus, beginning approximately on an unknown date in (b)(6)2018.Dose and frequency of insulin lispro protamine suspension 75%/insulin lispro 25% therapy was unknown.Sometimes she injected extra units of insulin lispro protamine suspension 75%/insulin lispro 25% therapy (reason unknown).On an unknown date, after 2014, while on insulin lispro therapy, sometimes her blood pressure raised up on four or five o clock in the afternoon in winter.When her blood pressure went high, she took a tablet of unknown antihypertensive drug as a corrective treatment.On an unknown date, she had toothache and face ache.Approximately in (b)(6)2019, she was hospitalized due to toothache and face ache.On an unknown date, after hospitalization she had trigeminal nerve surgery.After the surgery, she fell unwell about the throat, the voice was uncomfortable, the speech was laborious; half face, tongue and nose were numb; half brain was numb and she was unconscious.It was reported that she did not received any corrective treatment for unconscious.According to her treating physician it was a normal reaction after operation.Her mouth slightly askew/crooked mouth, mouth could not open big and eating was difficult.The events of facial asymmetry, intranasal hypoaesthesia, hypoaesthesia oral, eating disorder, dyskinesia, speech disorder, loss of consciousness, hypoaesthesia, toothache and facial pain were considered serious by the company due to their medical significance.In morning of (b)(6)2019, her tested blood glucose value was 3.3 (unit and reference range were not provided) and the hypoglycemia occurred.Also on (b)(6)2019 it was reported that on an unspecified date the humapen ergo ii was dropped and there was a crack on the pen cap after the pen was dropped.It was further reported that the crack on the pen cap got bigger and bigger and the patient worried the crack would expose the cartridge and affect the normal use of the humapen (product complaint (b)(4); lot number 1508d01).On an unknown date in (b)(6)2019, conflicting information received, she had hypoglycemia in nights (the blood sugar value was more than 2, no unit was provided).On an unknown date in (b)(6)2019, her face was pale, she had sweating, flustered, uncomfortable and hypoglycemia (the blood sugar value was 2.2, no unit was provided).The event of hypoglycemia was considered serious by the company due to its medical significance reason.On an unknown date, she had several uncomfortable feelings and her blood sugar values were 3.8, 3.9 and 4.0 (no unit or reference range was provided).On (b)(6)2019, she experienced dizziness, panic, heart shaking and sweating and she was recovered from these event on the same day.Information regarding any further corrective treatment and outcome of the events was not provided.Insulin lispro and insulin lispro protamine suspension 75%/insulin lispro 25% therapy were ongoing.The patient was the operator of humapen ergo ii and her training status was not provided.The general humapen ergo ii model duration of use was not provided.The suspect humapen ergo ii duration of use was approximately two years (since the suspect device was started in 2017).The action taken with the suspect humapen ergo ii device was unknown.The suspect humapen ergo ii device associated with product complaint (b)(4) was not returned to the manufacturer.The reporting consumer did not provide an assessment of relatedness between the events and insulin lispro drug or humapen.However, the reporting consumer thought the elevated blood pressure was related to the weather and her mood undulated/emotion.The reporting consumer did not relate the events of serious and non serious episodes of hypoglycemia with insulin lispro protamine suspension 75%/insulin lispro 25% therapy whereas did not provide an opinion of relatedness with remaining events.Update 02-jun-2019: additional information was received from initial reporting consumer via a psp on (b)(6)2019 was processed together.Added: corrective treatment of serious event of unconscious from unknown to no.Updated: as reported verbatim of event facial asymmetry.Narrative was updated with new information accordingly.Update 30-dec-2019: additional information was received from initial reporting consumer via a psp on (b)(6)2019 and a correction on (b)(6)2019 was processed together.Added blood sugar laboratory values.And one concomitant medication.Added one new suspect drug insulin lispro protamine suspension 75%/insulin lispro 25% and one serious event of hypoglycemia.Updated frequency of non serious event of hypoglycemia as intermittent.Narrative was updated with new information accordingly.Edit 14-jan-2020: upon review of the information received on 22-may-2019, suspect device age was added in product tab (and narrative) as well as the product complaint and lot number citation was also included in the narrative.No other changes were done into the case.Edit 14jan2020: updated medwatch fields for expedited device reporting.No new information added.Update 28jan2020: additional information received on 27jan2020 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 suspect humapen ergo ii device associated with product complaint (b)(4), which was not returned to the manufacturer.Corresponding fields and narrative updated accordingly.
 
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Brand Name
HUMAPEN ERGO II
Type of Device
FOR TREATMENT PURPOSES
Manufacturer (Section D)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis IN 46285
MDR Report Key9618223
MDR Text Key189835162
Report Number1819470-2019-00233
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K151686
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 02/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberMS9557
Device Lot Number1508D01
Was Device Available for Evaluation? No
Date Manufacturer Received01/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age76 YR
Patient Weight70
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