• 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 MEMOIR 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 MEMOIR FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9660
Device Problem Use of Device Problem (1670)
Patient Problems Headache (1880); Hematoma (1884); Hyperglycemia (1905); Swelling (2091); Arthralgia (2355)
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.
 
Event Description
(b)(4). This report is associated with product compliant: pending. This spontaneous case, reported by a consumer who contacted the company to report adverse events and a product complaint, concerned a (b)(6) female patient of unknown ethnicity. Medical history included diabetes since 1990. Concomitant medications were not provided. The patient received insulin lispro (rdna origin) (humalog, 100u/ml) through cartridge via reusable humapen memoir of unknown dose, subcutaneously for the treatment of diabetes mellitus beginning on an unknown date. She also received insulin glargine (lantus), valproate sodium (ergenyl), phenobarbital (luminal) (dosage regimen, route of administration and indication for use was unknown), unspecified medication for thyroid gland, unspecified pain killers and unspecified agents to widen her cardiac vessels (manufacturer, dosage regimen, route of administration and indication for use was unknown) beginning on an unknown date. On an unknown date after starting insulin lispro, insulin glargine, valproate sodium, phenobarbital, unspecified medication for thyroid gland, unspecified pain killers and unspecified agents to widen her cardiac vessels therapies, in the end of (b)(6) 2018 she had a knee surgery and she got a new patella. Due to her underlying diseases, she took insulin glargine, valproate sodium, phenobarbital, unspecified medication for thyroid gland, unspecified pain killers and unspecified agents to widen her cardiac vessels therapies and she had trouble with blood glucose. On (b)(6) 2018, due to high blood glucose she was hospitalized. More information regarding surgical procedures and laboratory tests during hospitalization was not provided. On (b)(6) 2018 her blood glucose was 200 mg/dl (reference ranges not provided) and she had nocturnal hypoglycemia. She also had her blood glucose value of 156 mg/dl on (b)(6) 2018. On an unknown date she also had knee pain with hematoma and swelling after the surgery and she also suffered from headache. She sometimes was unable to set the dosage of her humapen memoir ((b)(4)/ lot number- unknown). Corrective treatment was not provided. Outcome of the first episode of blood glucose increased (hospitalization) was recovered and for the remaining events was not provided. Status of insulin lispro, insulin glargine, valproate sodium, phenobarbital, unspecified medication for thyroid gland, unspecified pain killers and unspecified agents to widen her cardiac vessels therapies was not provided. Follow up would not be possible as there was no consent to follow up with reporter as well as treating physician. The operator of humapen memoir was patient and her training status was not provided. The general and suspect humapen memoir duration of use was not provided as they were started on an unknown date. The action taken and return status with respect to suspect humapen memoir was not provided. The reporting consumer assessed the event headache as not related to insulin lispro therapy but as related to weather, the reporting consumer did not provide any relatedness assessment between the remaining events and insulin lispro therapy. The reporting consumer did not provide relatedness assessment between the events and humapen memoir, did not provide relatedness assessment between the events and insulin glargine, valproate sodium, phenobarbital, unspecified medication for thyroid gland, unspecified pain killers and unspecified agents to widen her cardiac vessels therapies. Edit 19sep2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting. No new information added.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHUMAPEN MEMOIR
Type of DeviceFOR TREATMENT PURPOSES
Manufacturer (Section D)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis IN 46285
Manufacturer (Section G)
NYPRO, INC.
101 union street
clinton MA 01510
Manufacturer Contact
chris davis
lilly corporate center
indianapolis, IN 46285
3174334585
MDR Report Key7925545
MDR Text Key122315968
Report Number1819470-2018-00168
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K053563
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial,Followup
Report Date 11/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMS9660
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/30/2018
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: 10/02/2018 Patient Sequence Number: 1
-
-