• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN ERGO II FOR TREATMENT PURPOSES

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ELI LILLY AND COMPANY HUMAPEN ERGO II FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9557
Device Problem Mechanical Problem (1384)
Patient Problems Hyperglycemia (1905); Pain (1994)
Event Type  Injury  
Manufacturer Narrative
Description of problem or event: new, updated and corrected information is referenced within the update statements. Please refer to update statement. No further follow-up is planned. Evaluation summary: a male patient reported that the injection button of his humapen ergo ii device was not very flexible and pushed down very slowly during injection, causing strong pain. The patient experienced increased blood glucose. The device was not returned to the manufacturer for investigation (batch number unknown). Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction. Malfunction unknown. 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. There is no evidence of improper use or storage.
 
Event Description
Lilly case id: (b)(4). This report is associated with product compliant: (b)(4). This solicited case, reported by a consumer via a patient support program (psp), additional information was received from second reporter, concerned a (b)(6)-year-old asian male patient. Medical history included hypertension, arteriosclerosis, leg numbness and allergy to penicillin. His elder sister had diabetes and father was allergic to penicillin. Concomitant medications included acarbose and metformin for diabetes mellitus and epalrestat for unknown indication. The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) injections (humalog mix 50) with unknown formulation via a reusable device huma pen ii (humapen ergo ii) at an unknown dose and frequency subcutaneously for treatment of the type ii diabetes mellitus beginning in 2018. On an unknown date while taking insulin lispro protamine suspension 50%/insulin lispro 50% treatment he had bad blood glucose level and fasting blood glucose was more than 20 (units and reference range were not provided) due to which he was hospitalized for regulating blood glucose level. After hospitalization on physician advice he switched to insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) (humalog mix 25), via cartridge, twice a day (morning 26 iu, night 16 iu), subcutaneously, for the type ii diabetes mellitus, beginning approximately on (b)(6) 2019. On an unknown date, when injecting insulin lispro protamine suspension 75%/insulin lispro 25%, it was very painful when the injection pen pushed in. It was noted the injection button of the humapen ergo ii was not very flexible and it was pushed down very slowly during injection (product complaint (b)(4) /lot number unknown). Information regarding any further hospitalization details, corrective treatments, outcome of the events was not provided. Insulin lispro protamine suspension 75%/insulin lispro 25% treatment was continued. It was unknown if he would re-start insulin lispro protamine suspension 50%/insulin lispro 50% treatment or not. The operator of the device and his/her training status was not reported. The general humapen ii model duration of use and suspect device model duration of use was around six months. The suspect humapen ergo ii device associated with product complaint (b)(4) was not returned to the manufacturer. The reporting consumer did not provide a relatedness assessment between the events and insulin lispro protamine suspension 75%/insulin lispro 25% and insulin lispro protamine suspension 50%/insulin lispro 50% treatments or humapen ii device. Update 07-jun-2019: this case was determined to be non-valid since there was no identifiable valid adverse event reported. Update 17-jun-2019: the case was downgraded to non-serious and became valid after additional information was received on (b)(6) 2019 from second reporter via psp. Added a new reporter, all medical histories, three concomitant medications and weight, height of patient. Added a suspect medication humalog 25 and suspect device. Deleted the suspect humalog 50 and added in historical medication. Deleted the serious event of hospitalization and added a non-serious event of injection site pain. Updated the narrative with new information. Update 21-jun-2019: additional information was received on (b)(6) 2019 from rcp regarding pc number (b)(4). The action item to monitor pc was set accordingly. No new medically significant information was received and no changes were done to the case. Update 12-jul-2019: additional information was received from the initial reporter via the psp on 10-jul-2019. This case was upgraded to serious (p1) due to addition of serious event of fasting blood glucose increased due to hospitalization and associated with reusable device humapen ergo ii. Added new suspect with insulin lispro protamine suspension 50%/insulin lispro 50% treatment with associated serious event of fasting blood glucose increased and deleted from historical medication and lab test with fasting blood glucose with values of more than 20. Updated eu/(b)(4) field of reusable device humapen ergo ii, causality statement and narrative with new information. Edit 18jul2019: updated medwatch fields for expedited device reporting. No new information added. Update 22jul2019: additional information received on 22jul2019 from the global product complaint database. Entered device specific safety summary (dsss). Updated the medwatch fields with device information and the european and (b)(4) (eu/(b)(4)) device information 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8841717
MDR Text Key152792226
Report Number1819470-2019-00137
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 07/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS9557
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/09/2020
Was Device Evaluated by Manufacturer? No
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: 07/30/2019 Patient Sequence Number: 1
-
-