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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 Improper or Incorrect Procedure or Method (2017)
Patient Problems Dyspnea (1816); Weakness (2145); Dizziness (2194)
Event Type  Injury  
Manufacturer Narrative
Narrative field: new, updated and corrected information is referenced within the update statements in b. 5. Please refer to update statement(s) dated 07nov2019. No further follow-up is planned. Evaluation summary: a male patient reported that the injection button of his humapen ergo ii device was difficult to press. The patient experienced increased blood glucose. The device was not returned for investigation (batch unknown). With the guidance of a trained professional, the patient changed the needle and primed the pen, and the issue was resolved. 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 patient reported visual impairment. 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. There is evidence of improper use. The patient used the device while visually impaired. It is unknown if this misuse is relevant to the event of increased blood glucose.
 
Event Description
Lilly case id: (b)(4). This report is associated with product compliant: (b)(4). This spontaneous case reported by a consumer who contacted the company to report adverse events and a product complaint (pc), concerned a (b)(6) asian male patient. Medical history included hemiplegia, numbness of hands and feet and family history of diabetes mellitus. Concomitant medications were not reported. The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injection (humulin 70/30, 100u/ml) from cartridge via reusable humapen ergo ii pen at 13 in the morning and 12 at night (no units provided) subcutaneously for the treatment of diabetes mellitus beginning sometime in 2017. Sometime in 2017, as the injection site was in the abdomen and he thought the process of insulin injection was troublesome, he changed the dose by himself to 11 in the morning and 10 in the evening (no units provided). On unknown date, he discontinued human insulin isophane suspension 70%/human insulin 30% by himself and changed it to oral medication. Sometime in 2017, the injection pen of the humapen ergo ii appeared the condition that it was difficult to press the injection button (unknown lot number/ pc 4932940). On unknown date, because of poor blood sugar control; high blood sugar and blood glucose value was 28. 5 (no units and normal ranges provided) and poor eyes (no further details provided), he was hospitalized. On (b)(6) 2019, there was a situation of dizziness, weakness and lack of breath. He was hospitalized due to events of dizziness, weakness and lack of breath. Further details about hospitalization such as admission and discharge dates, any relevant laboratory data or corrective treatment was provided. Reportedly, he performed a troubleshot and the humapen ergo ii worked correctly. As of (b)(6) 2019, he restarted human insulin isophane suspension 70%/human insulin 30% to control blood sugar based on the doctor instructions. On an unknown date, his doctor prescribed the wrong drug to him, he received yousilin 30/70 (as reported) instead of human insulin isophane suspension 70%/human insulin 30%, for the treatment of diabetes mellitus. Dosage regimen for yousilin 30/70 was not provided. Reportedly, the cartridge of yousilin 30/70 could not be loaded on the humapen ergo ii injection pen. Information regarding outcome and corrective treatment was unknown. Status of human insulin isophane suspension 70%/human insulin 30% and yousilin 30/70 was not provided. The operator of the humapen ergo ii was the patient who had poor eyes and his training status was unknown. The general humapen ergo ii model duration of use was unknown and the reported suspect humapen ergo ii duration of use was two years (beginning it since 2017). The humapen ergo ii was troubleshot and thus, it was not expected to be returned. The reporting consumer did not provide a relatedness assessment for the events of dizziness, weakness, lack of breath and intercepted wrong drug selected to human insulin isophane suspension 70%/human insulin 30% therapy and humapen ergo ii. The reporting consumer did not relate the remaining events to human insulin isophane suspension 70%/human insulin 30 and or the humapen ergo ii. The reporting consumer did not provide a relatedness assessment for the event of intercepted wrong drug selected to yousilin 30/70 therapy and the remaining events were not associated with yousilin 30/70. This case was cross-referenced to the following one: (b)(4) (same patient). Edit (b)(6) 2019: updated medwatch fields for expedited device reporting. No new information added. Update (b)(6) 2019: additional information received on 06nov2019 from the global product complaint database. Entered device specific safety summary (dsss). Updated the medwatch fields/ european and canadian (eu/ca) device information, malfunction from unknown to no, and device return status to not returned to manufacturer for pc (b)(4) associated with an unknown lot of a humapen ergo ii device. Corresponding fields and narrative updated accordingly. Update (b)(6) 2019: additional information was received from initial reporter on 11-nov-2019. Added medical history (hemiplegia), serious events (dizziness, weakness, lack of breath) and non-serious events (intercepted wrong drug selected). Updated the action taken and status of human insulin isophane suspension 70%/human insulin 30% therapy. Updated the causality statement and narrative with new information.
 
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Brand NameHUMAPEN ERGO II
Type of DeviceFOR TREATMENT PURPOSES
Manufacturer (Section D)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis IN 46285
Manufacturer (Section G)
PHILLIPS-MEDISIZE CORPORATION
415 red cedar street
medical device manufacturing
menomonie WI 54751
Manufacturer Contact
chris davis
lilly corporate center
indianapolis, IN 46285
3174334585
MDR Report Key9351239
MDR Text Key167773823
Report Number1819470-2019-00207
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
Report Date 11/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMS9557
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/30/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/20/2019 Patient Sequence Number: 1
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