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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 Problems Connection Problem (2900); Activation, Positioning or Separation Problem (2906)
Patient Problems Neuropathy (1983); Pain (1994); Visual Impairment (2138); Numbness (2415); Missed Dose (2561); Blood Loss (2597); Weight Changes (2607)
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
(b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and product compliant (pc), concerned an (b)(6) female patient of (b)(6) nationality.Medical history included the eyes were not good.Concomitant medication included five oral drugs about reducing blood fat and reducing cholesterol, digestive drugs, drugs for soften blood vessels, statin calcium and naobaijin (as reported) for unknown indication.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) injections (humalog mix 50, 100u/ml) from cartridge via reusable device (humapen ergo ii), twice daily, subcutaneously for treatment of diabetes mellitus beginning on an unknown date (from more than ten years ago at the time of report).Dosage was not provided.On an unknown date after starting insulin lispro protamine suspension 50%/insulin lispro 50% therapy, the injection site abdomen was sometimes painful.Sometimes after injection, the needle was pulled out after staying in the body for more than five seconds after the injection completed, there was bleeding on the injection site abdomen.She experienced fundus bleeding and she underwent laser surgery due to it.She also experienced peripheral neuropathy and some lesions appeared sensory nerve ending.She had feet numbness, due to her old age.On an unknown date, she adjusted the dosage which sometimes was 15iu, or 16iu, or 17iu to 21iu, or 22iu, or 23iu due to unknown reason.She possibly had abnormal blood glucose and she was always hospitalized for regulating it.Her memory was not good.On (b)(6) 2019 (specific date was not provided), the cartridge holder could not connect with humapen ergo ii closely.Also, there were small objects at the joint of cartridge holder and humapen ergo ii (pc (b)(4)/lot number 1306d01).Reportedly, the insulin lispro protamine suspension 50%/insulin lispro 50% cartridge did not have problems, but the humapen ergo ii had issue.Also, her eyes could not see (also reported as could not see clearly), so she did not know the insulin lispro protamine suspension 50%/insulin lispro 50% was injected into the body or not and did not know how much insulin lispro protamine suspension 50%/insulin lispro 50% was injected into the body.The events fundus bleeding and eyes could not see were considered serious due to medical significance.As of (b)(6) 2019, her weight had increased by 5kg after she had been on insulin lispro protamine suspension 50%/insulin lispro 50% (from 45kg prior insulin lispro protamine suspension 50%/insulin lispro 50% to 60kg).No more details regarding admission and discharge dates as well as treatment and laboratory tests done while hospitalized were provided.Information regarding corrective treatment and outcome for the events were not provided.Insulin lispro protamine suspension 50%/insulin lispro 50% therapy was ongoing.The patient was the operator of the humapen ergo ii and her training status was not provided.The humapen ergo ii device model duration of use and suspect humapen ergo ii device duration of use were not provided.The use of the suspect humapen ergo ii was ongoing and its return status was not provided.The reporting consumer did not know if the events were related to the insulin lispro protamine suspension 50%/insulin lispro 50% therapy.The reporting consumer related the events of missed dose and incorrect dose administered to the humapen ergo ii device issue and did not provide a relatedness assessment for the remaining events to the humapen ergo ii.Update 12-sep-2019: information received on 09-sep-2019, 10-sep-2019 and 11-sep-2019 were processed together.Edit 18-sep-2019: upon internal review on 13-sep-2019 of the initial information, the event of radiculopathy was deleted and the as determined causality for the events of blood glucose abnormal, retinal hemorrhage, blindness, neuropathy peripheral, weight increased, memory impairment, product dose omission and incorrect dose administered was changed from unknown to no, as requested upon medical review.Edit 30sep2019: 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(s) dated 09oct2019 in the b.5.Field.No further follow-up is planned.Evaluation summary: a female patient reported that the cartridge holder of her humapen ergo ii device could not connect closely and there were small objects at the joint of cartridge holder.The patient also reported she is visually impaired and did not know if insulin was injected or how much was injected.The patient experienced abnormal blood glucose.The device was not returned to the manufacturer for investigation (1306d01, manufactured june 2013).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 regard to foreign material contamination, cartridge holder attachment/removal, or 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 with high probability.The core instructions for use states that the device is not recommended for the visually impaired without the assistance of a sighted individual trained to use it.The core instructions for use also states if any of the parts of your humapen ergo ii appear broken or damaged, do not use.There is evidence of improper use.The patient used the device while visually impaired and used the device after experiencing cartridge holder issues.These misuses may be relevant to the event of abnormal blood glucose.
 
Event Description
Lilly case id: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and product compliant (pc), concerned an 81-years-old female patient of han nationality.Medical history included the eyes were not good.Concomitant medication included five oral drugs about reducing blood fat and reducing cholesterol, digestive drugs, drugs for soften blood vessels, statin calcium and naobaijin (as reported) for unknown indication.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) injections (humalog mix 50, 100u/ml) from cartridge via reusable humapen ergo ii device, twice daily, subcutaneously for treatment of diabetes mellitus beginning on an unknown date (from more than ten years ago at the time of report).Dosage was not provided.On an unknown date after starting insulin lispro protamine suspension 50%/insulin lispro 50% therapy, the injection site abdomen was sometimes painful.Sometimes after injection, the needle was pulled out after staying in the body for more than five seconds after the injection completed, there was bleeding on the injection site abdomen.She experienced fundus bleeding and she underwent laser surgery due to it.She also experienced peripheral neuropathy and some lesions appeared sensory nerve ending.She had feet numbness, due to her old age.On an unknown date, she adjusted the dosage which sometimes was 15iu, or 16iu, or 17iu to 21iu, or 22iu, or 23iu due to unknown reason.She possibly had abnormal blood glucose and she was always hospitalized for regulating it.Her memory was not good.On (b)(6) 2019 (specific date was not provided), the cartridge holder could not connect with humapen ergo ii closely.Also, there were small objects at the joint of cartridge holder and humapen ergo ii ((b)(4)/lot number 1306d01).Reportedly, the insulin lispro protamine suspension 50%/insulin lispro 50% cartridge did not have problems, but the humapen ergo ii had issue.Also, her eyes could not see (also reported as could not see clearly), so she did not know the insulin lispro protamine suspension 50%/insulin lispro 50% was injected into the body or not and did not know how much insulin lispro protamine suspension 50%/insulin lispro 50% was injected into the body.The events fundus bleeding and eyes could not see were considered serious due to medical significance.As of (b)(6) 2019, her weight had increased by 5kg after she had been on insulin lispro protamine suspension 50%/insulin lispro 50% (from 45kg prior insulin lispro protamine suspension 50%/insulin lispro 50% to 60kg).No more details regarding admission and discharge dates as well as treatment and laboratory tests done while hospitalized were provided.Information regarding corrective treatment and outcome for the events were not provided.Insulin lispro protamine suspension 50%/insulin lispro 50% therapy was ongoing.The patient was the operator of the humapen ergo ii and her training status was not provided.The humapen ergo ii device model duration of use and suspect humapen ergo ii device duration of use were not provided.The use of the suspect humapen ergo ii, which was manufactured in jun2013, was ongoing and it was not returned to the manufacturer.The reporting consumer did not know if the events were related to the insulin lispro protamine suspension 50%/insulin lispro 50% therapy.The reporting consumer related the events of missed dose and incorrect dose administered to the humapen ergo ii device issue and did not provide a relatedness assessment for the remaining events to the humapen ergo ii.Update 12-sep-2019: information received on 09-sep-2019, 10-sep-2019 and 11-sep-2019 were processed together.Edit 18-sep-2019: upon internal review on 13-sep-2019 of the initial information, the event of radiculopathy was deleted and the as determined causality for the events of blood glucose abnormal, retinal hemorrhage, blindness, neuropathy peripheral, weight increased, memory impairment, product dose omission and incorrect dose administered was changed from unknown to no, as requested upon medical review.Edit 30sep2019: updated medwatch fields for expedited device reporting.No new information added.Update 09oct2019: additional information received on 08oct2019 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information, and device return status to not returned to manufacturer.Added date of manufacturer for (b)(4) associated with lot 1306d01 of humapen ergo ii device.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 Key9167148
MDR Text Key172923379
Report Number1819470-2019-00170
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 consumer,foreign
Type of Report Initial,Followup
Report Date 10/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2019
Is this an Adverse Event Report? Yes
Device Operator Lay User/Patient
Device Model NumberMS9557
Device Lot Number1306D01
Was Device Available for Evaluation? No
Date Manufacturer Received10/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age81 YR
Patient Weight60
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