• 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, UNKNOWN DEVICE 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, UNKNOWN DEVICE FOR TREATMENT PURPOSES Back to Search Results
Model Number UNKNOWN
Device Problem Failure to Deliver (2338)
Patient Problems Hypoglycemia (1912); Shaking/Tremors (2515)
Event Type  Injury  
Manufacturer Narrative
Since the device is not being returned, evaluation for a malfunction is not possible.
 
Event Description
(b)(4). This solicited case, reported by a consumer via patient support program (psp), with additional information received from another consumer reporter via psp, concerned a (b)(6) female patient of unknown ethnicity. Medical history included type one diabetes mellitus (conflicting), was not reported. Concomitant medications included repaglinide (unknown indication), ramipril (hypertension), carvedilol (hypertension), thioctic acid (nerve ending pain), cortisone (nerve ending pain), salbutamol (nerve ending pain), rosuvastatin calcium (cholesterol), candesartan cilexetil and hydrochlorothiazide (hypertension), and unspecified diabetes pill for unknown indication. The patient received human insulin isophane suspension 70%/ human insulin 30% (rdna origin) injections (humulin 70/30) via an unknown formulation through a reusable pen (humapen unknown), at unknown dose and frequency, for the treatment of type 2 diabetes, beginning approximately in 2002. She also received unspecified insulin drug (manufacturer unknown) early in the morning while in hospital. Dose, frequency, route and indication were not reported. On an unknown date, while on human insulin isophane suspension 70%/ human insulin 30%, she could not get insulin due to humapen not releasing medication completely ((b)(4), lot unknown) for two months due to which she experienced increasing of blood glucose value. She was hospitalized for 21 days. She was taking half of her diabetes pill before bed at night. On an unknown date, while she was sleeping, her blood glucose value decreased. She woke up with tremor. She was using other unspecified insulin drug early in the morning which was given in the hospital and received dialysis treatment due to high insulin level for her kidneys. The outcome of events was reported as not recovered. Information regarding additional corrective treatment was not provided. Status of human insulin isophane suspension 70%/ human insulin 30% and unspecified insulin was not provided. The patient was the operator of the humapen and her training status was not reported. The general and suspect devices durations of use were not reported. The humapen was discarded and was not returned to the manufacturer. The reporting consumers did not provide opinion of relatedness between events, unspecified insulin and human insulin isophane suspension 70%/ human insulin 30% or the humapen device update 18-dec-2017: information received on 11-dec-2017 and 15-dec-2017 was processed together. Edit 21-dec-2017: upon review of initial report, added missing listedness for the event of kidney disorder. Update 09-jan-2018: additional information received from another reporter via psp on (b)(6) 2018. Added type one diabetes mellitus as conflicting medical history. Added repaglinide, ramipril, carvedilol, thioctic acid, cortisone, salbutamol, rosuvastatin calcium, candesartan cilexetil and hydrochlorothiazide as concomitant medications. Updated narrative with new information. Edit 26-jan-2018: upon review of initial information received on 11-jan-2018 added a suspect unknown humapen device and the priority of the case was changed from p2 to p1. Updated narrative with new information. Update 26-jan-2018: additional information received from the rcp on 16-jan-2018. (b)(4) was processed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHUMAPEN, UNKNOWN DEVICE
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 Key7238373
MDR Text Key98923855
Report Number1819470-2018-00009
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 02/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/29/2018
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: 02/02/2018 Patient Sequence Number: 1
-
-