• 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, TEAL/CLEAR 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, TEAL/CLEAR FOR TREATMENT PURPOSES Back to Search Results
Model Number MS8929
Device Problems Improper or Incorrect Procedure or Method (2017); Device Operational Issue (2914); Inaccurate Dispensing (2955)
Patient Problems Abscess (1690); Hyperglycemia (1905)
Event Type  Injury  
Manufacturer Narrative
Narrative field; new updated and corrected information is referenced within the update statements in describe event or problem. No further follow-up is planned. Evaluation summary: a female patient reported the cartridge holder of her humapen ergo device could not be closely connected to the pen and she thought the dosage was inaccurate. The patient experienced increased blood glucose levels. Investigation of the returned device (batch (b)(4), manufactured august 2005) found the front outer housing / rear outer housing glue bond had failed. Malfunction confirmed. The front outer housing / rear outer housing glue bond will fail upon exposure to excessive force. The user manual instructs patients to not use the device if any part of the device appears broken or damaged and to contact lilly or a healthcare professional. There is evidence of improper use. The device was exposed to excessive force which caused the rear outer housing / front outer housing glue bond to fail.
 
Event Description
(b)(4). This solicited case reported by a consumer via a patient support program (psp), with additional information from the initial reporter via psp, concerned a (b)(6) female patient. Medical history included hypertension. Concomitant medications included metformin and acarbose, both for unknown indications. The patient received human insulin isophane suspension 70%/ human insulin 30% (rdna origin) injection (humulin 70/30-100 u/ml) through a cartridge via reusable pen (humapen ergo), 76 units divided on 38 units at morning, 10 units at noon and 28 units at night subcutaneously, for the treatment of diabetes mellitus beginning 10 years ago (approximately in 2006). On an unknown date, she experienced high blood sugar; her fasting glucose was 21 (no units provided) and her post-prandial blood glucose was 18 (no units provided). Also, she had three abscesses above her right wrist that did not occur at the injection site and she did not require drainage or antibiotic treatment. On (b)(6) 2016, due to high blood sugar and the abscesses, she was hospitalized. In (b)(6)2016, due to unknown reasons, her human insulin 70/30 dose changed to 50 units divided on 30 units at morning and 20 units at night. She was discharged from hospital on (b)(6) 2016. No laboratory findings were reported. In (b)(6) 2016 her humapen ergo failed and her dose was inaccurate ((b)(4)/ lot number 0508a01). Information regarding corrective treatments and outcome of events was unknown. Human insulin isophane suspension 70%/ human insulin 30% was continued. The patient was the operator of the humapen ergo and her training status was not provided. The humapen ergo model and suspect humapen ergo duration of use was of approximately three years. The humapen ergo device returned on 17nov2016, malfunction confirmed. There was evidence of improper use, the device was used beyond the life expectancy. The reporting consumer did not know if the events were related to human insulin isophane suspension 70%/ human insulin 30% and did not provide an assessment of relatedness between the events and the humapen ergo. Edit 25-nov-2016: pc number was provided and device was updated as humapen ergo teal instead unknown body. Narrative was updated with pc and lot number. Update 06-dec-2016: additional information received from the initial reporter via a psp on 02-dec-2016. Added information about abscesses location and treatment. Updated narrative with new information. Update 16-dec-2016: information received from the rcp on 14-nov-2016 (b)(4) was received; however it was previously processed. No adverse event information was received. Upon internal review, it was corrected the as reported causality for the event of blood glucose increased and humapen ergo (from not associated to device nhcp). No additional changes were performed. Update 27dec2016. Additional information received 25dec2016 from the product complaint safety database. To the device tab added the device specific safety summary (dsss), updated the european and canadian (eu/ca) device information, updated the device medwatch information, changed improper use to yes, date of manufacture, malfunction to yes, date returned to the manufacture, and the narrative was updated accordingly.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHUMAPEN ERGO, TEAL/CLEAR
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
caroline rosewell
lilly corporate center
indianapolis, IN 46285
3172764376
MDR Report Key6250375
MDR Text Key64911359
Report Number1819470-2016-00345
Device Sequence Number1
Product Code FMF
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
Report Date 01/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMS8929
Device Lot Number0508A01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/17/2016
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/25/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2005
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: 01/13/2017 Patient Sequence Number: 1
Treatment
ACARBOSE; INSULIN HUMAN; METFORMIN
-
-