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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN ERGO; FOR TREATMENT PURPOSES
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ELI LILLY AND COMPANY HUMAPEN ERGO; FOR TREATMENT PURPOSES Back to Search Results
Model Number UNKNOWN
Device Problems Crack (1135); Mechanical Problem (1384)
Patient Problems Diarrhea (1811); Hypoglycemia (1912); Vomiting (2144); Weakness (2145); Discomfort (2330); Complaint, Ill-Defined (2331); Diabetic Ketoacidosis (2364); Sweating (2444); Constipation (3274)
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.This report is associated with 1819470-2016-00164, since there is more than one device implicated.
 
Event Description
(b)(4).This solicited case, reported by a consumer via patient support program (psp), with additional information from the initial reporter, concerned a (b)(6) female patient.Medical history included cardiac and cerebral vascular disease and peripheral neuropathy (mainly manifested as legs pain).Concomitant medications included mecobalamin for unknown indication and unspecified medication for fundus hemorrhage.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humulin mix 70/30)cartridge via reusable unknown humapen, for the treatment of diabetes mellitus, subcutaneously, 34 iu in the morning and 20 iu in the evening, beginning in 2000.She also used a humapen ergo that was purchased in 2000.On an unknown date, she sometimes had hypoglycemia with sweating, weakness symptoms, if she did not have her meals.On an unspecified date, patient was hospitalized due to ketoacidosis for five or six times, at that time she had a potassium deficiency problem.She normally experienced bloating, indigestion, constipation, loose stool symptom and at the hospital she had a hemangioma found.In 2011, received laser surgery due to fundus hemorrhage (event considered serious for medical significance), and at that time she was diagnosed with cataract which developed fast.The last hospitalization due to ketoacidosis was at the spring of 2014.In (b)(6) 2015, her injection pen cap was cracked on her unknown humapen ((b)(4)/ lot unknown) and she was given a humapen ergo ii as a replacement.In (b)(6) 2016 she found the injection button had no pressure on her humapen ergo (product complaint 3702319/ lot 0405a02), and doubted that the insulin was not injected into her body.In (b)(6) 2016, the injection pen screw rod could not be pushed on her humapen ergo.On an unspecified date, in 2016, she had a cold and her blood glucose was 22 (no reference values or units provided), at the same time she had stomach discomfort and was vomiting.Information regarding additional corrective treatment and outcome of events was unknown.Human insulin isophane suspension 70%/human insulin 30% treatment was continued.The patient was the user of the device and her training status was not provided.The general device duration of use was since 2000.The durations of use for the suspect devices was as follows: unknown humapen and the humapen ergo were in use since 2000, but the unknown humapen was discontinued in (b)(6) 2015; the humapen ergo ii was in use since (b)(6) 2015.The unknown humapen was not available for return.The status of the humapen ergo and humapen ergo ii was not provided.The reporting consumer did not know whether the events were related to human insulin isophane suspension 70%/human insulin 30% therapy and its device or not.Edit 01-jul-2016: upon review of internal information humapen ergo was unrelated to the ketoacidosis event and associated to ns events.Update 01-jul-2016: upon review, this case was opened to update the medwatch for regulatory reporting.Update 08-jul-2016: follow up attempt was made, but the reporter was very busy and refused to provide information.No new adverse event or product information was received.Edit 08-jul-2016: added product complaint numbers to narrative.
 
Manufacturer Narrative
No further follow up is planned.This report is associated with 1819470-2016-00164, since there is more than one device implicated.Continued: evaluation summary: a female patient reported in (b)(6) 2016 that the injection button on her humapen ergo device "had no pressure" and she doubted that the insulin was injected into her body.In (b)(6) 2016, she reported that the "injection pen screw rod could not be pushed" on her humapen ergo device.She experienced ketoacidosis.Investigation of the returned device (batch 0405a02, manufactured may2004) found that the device met functional requirements and met dose accuracy and glide (injection) force specifications.No malfunction was identified.While the exact date the patient started using the device could not be determined, it is likely the patient used the device beyond its approved use life based on the amount of time elapsed since it was manufactured (2004).The user manual states the humapen ergo has been designed to be used for up to 3 years after first use.There is evidence of improper use.The patient likely used the device beyond its approved use life, but the extended use may not be relevant to the complaint of ketoacidosis as the device met functional requirements and met dose accuracy and glide (injection) force specifications.
 
Event Description
Lilly case id: (b)(6).This solicited case, reported by a consumer via patient support program (psp), with additional information from the initial reporter, concerned a (b)(6) chinese female patient.Medical history included cardiac and cerebral vascular disease, peripheral neuropathy (mainly manifested as legs pain), diabetes and ketoacidosis since 1998.Concomitant medications included mecobalamin for unknown indication and keyuan (as reported) for fundus hemorrhage.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humulin mix 70/30) cartridge via reusable unknown humapen, for the treatment of diabetes mellitus, subcutaneously, 28 iu in the morning and 18 iu in the evening, beginning in 2000.She also used a humapen ergo that was purchased in 2000.On an unknown date, she sometimes had hypoglycemia with sweating, weakness symptoms, if she did not have her meals.On an unspecified date, patient was hospitalized due to ketoacidosis for five or six times, at that time she had a potassium deficiency problem.She normally experienced bloating, indigestion, constipation, loose stool symptom and at the hospital she had a hemangioma found.In 2011, received laser surgery due to fundus hemorrhage (event considered serious for medical significance), and at that time she was diagnosed with cataract which developed fast.The cause of the retinal bleeding in fundus was diabetes.The last hospitalization due to ketoacidosis was at the spring of 2014.Since this hospitalization, his dosage was changed to 34 iu in the morning and 20 iu in the evening.In (b)(6) 2015, her injection pen cap was cracked on her unknown humapen (product complaint (b)(4) and lot unknown) and she was given a humapen ergo ii as a replacement.In (b)(6) 2016 she found the injection button had no pressure on her humapen ergo (product complaint (b)(4) and lot 0405a02), and doubted that the insulin was not injected into her body.In (b)(6) 2016, the injection pen screw rod could not be pushed on her humapen ergo.On an unspecified date, in 2016, she had a cold and her blood glucose was 22 (no reference values or units provided), at the same time she had stomach discomfort and was vomiting.Information regarding additional corrective treatment and outcome of events was unknown.As of (b)(6) 2016, her corrected visual acuity was around 0.3 to 0.4, she could now read via megaloscope.Human insulin isophane suspension 70%/human insulin 30% treatment was continued.The patient was the user of the device and her training status was not provided.The general device duration of use was since 2000.The durations of use for the suspect devices was as follows: unknown humapen and the humapen ergo were in use since 2000, but the unknown humapen was discontinued in (b)(6) 2015; the humapen ergo ii was in use since (b)(6) 2015.The unknown humapen was not available for return.The humapen ergo was returned on 06jul2016, and no malfunction was found.The status of the humapen ergo ii was not provided.The reporting consumer did not know whether the events were related to human insulin isophane suspension 70%/human insulin 30% therapy and its suspect device or not; but assessed the events of hypoglycemia and retinal bleeding (in fundus) were associated with diabetes.Edit 01jul2016: upon review of internal information humapen ergo was unrelated to the ketoacidosis event and associated to ns events.Update 01jul2016: upon review, this case was opened to update the medwatch for regulatory reporting.Update 08jul2016: follow up attempt was made, but the reporter was very busy and refused to provide information.No new adverse event or product information was received.Edit 08jul2016: added product complaint numbers to narrative.Update 14jul2016: additional information received from the initial reporter via psp on 11jul2016.Added medical history, concomitant medication in narrative, dosage regimen and causality paragraph updated.Updated narrative accordingly.Update 15-jul-2016: follow up information received on 29-jun-2016, included product complaint which was previously processed.No new adverse event information was added to the case.Update 01aug2016: additional information received on 29jul2016 from the global product complaint database added device specific safety summary for the unknown humapen, and the humapen ergo; added the return date for the humapen ergo; updated the improper use and storage to yes for both devices; updated the malfunction field to no for the humapen ergo; updated the medwatch and european and canadian required device reporting elements for both devices; and updated the narrative.
 
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Brand Name
HUMAPEN ERGO
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
medical device manufacturing
415 red cedar street
menomonie WI 54751
Manufacturer Contact
caroline rosewell
lilly corporate center
indianapolis, IN 46285
3172764376
MDR Report Key5793643
MDR Text Key49508897
Report Number1819470-2016-00165
Device Sequence Number1
Product Code NSC
Combination Product (y/n)N
PMA/PMN Number
K982842
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 06/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberUNKNOWN
Device Lot Number0405A02
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2016
Date Manufacturer Received07/29/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2004
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age65 YR
Patient Weight65
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