Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 Problems Break (1069); Crack (1135); Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Reportable malfunction/incident identified.Investigation in progress.A follow-up report will be submitted when the final evaluation is completed as necessary.
 
Event Description
Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This device case, which does not involve an adverse event, reported by a consumer who contacted the company with a product complaint, concerns a patient of an unknown age, gender, and ethnicity.The patient was taking human insulin via humapen ergo ii for the treatment of an unknown indication.The dose, route, frequency, indication for use, and start date were not provided.On (b)(6) 2021, the whole cartridge holder of the humapen ergo ii pen was broken and further described that the black injection screw was also cracked.This device was associated with product complaint (b)(4)/lot number 1406d01.The operator and training status of the user was unknown.The duration of use for the device model and start of use was unknown.The device was returned on 31may2021.
 
Manufacturer Narrative
B.5.Narrative field; new updated and corrected information is referenced within the update statements in b.5.Please refer to statement dated 12jul2021 in the b.5.Field.No further follow up is planned.Evaluation summary: patients family reported cartridge holder of patient's humapen ergo ii device was broken, injection screw was cracked.There was no reported adverse event.Initial assessment of sample found device was returned in pieces.Abd clicker was not returned with rest of pieces; therefore, complaint was initially associated with a reportable malfunction of a missing abd clicker, which could lead to an under dose.Investigation of returned device (batch 1406d01, manufactured jun2014) found pen housing was cracked and multiple components were separated from device including front housing.An impact point/field damage was observed in proximity of cracked area of pen body.Reportable malfunction of missing abd clicker is not confirmed since multiple components of device separated from pen body to include abd clicker (not returned) and abd spring, drive sleeve, nut floating spring, injection nut, drive clutch, injection screw.Without these components, device is rendered inoperable.Beginning use date by user is unknown.Device was manufactured in jun2014 and based on appearance of returned complaint sample (cracked pen housing, faded cartridge holder printing, de-bonding soft touch and broken cap), is apparent device has been used while in field for a significant amount of time.A missing abd clicker component would be apparent to user early in its use period.Note that abd clicker is smallest of separated components and could easily be lost when device came apart due to crack in pen housing while in field.A nonreportable malfunction of device is confirmed due to damage in field.All humapen ergo ii devices are assessed for injection screw travel at end of manufacturing process, ensuring device functionality and dose accuracy with high probability.A device in condition of returned device would not be released.Core instructions for use provide proper care and storage instructions.There is evidence of improper use or storage.Breakage of device occurred while in field.
 
Event Description
Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This device case, which does not involve an adverse event, reported by a consumer who contacted the company with a product complaint, concerns a patient of an unknown age, gender, and ethnicity.The patient was taking human insulin via humapen ergo ii for the treatment of an unknown indication.The dose, route, frequency, indication for use, and start date were not provided.On (b)(6) 2021, the whole cartridge holder of the humapen ergo ii pen was broken and further described that the black injection screw was also cracked.This device was associated with product complaint (b)(4) /lot number 1406d01.The operator and training status of the user was unknown.The duration of use for the device model and start of use was unknown.The device was returned on (b)(4) 2021.Update 01jul2021: additional information was received from the global product complaint database on (b)(6) 2021 for the pc (b)(4).As a device specific safety summary was not provided by gps, the malfunction and malfunction type were not updated to no at this time.No new information provided.Update 12jul2021: additional information received on 02jul2021 from the global product complaint database.Entered the device specific safety summary (dsss).Updated the medwatch and european and canadian (eu/ca) device fields, improper use and storage from no to yes, malfunction from yes/cirm to yes/not cirm.Added the date of manufacture and date returned to manufacturer for the suspect device associated with (b)(4).Corresponding fields and narrative updated accordingly.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HUMAPEN ERGO II
Type of Device
FOR TREATMENT PURPOSES
Manufacturer (Section D)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis IN 46285
MDR Report Key12060636
MDR Text Key261236028
Report Number1819470-2021-00079
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,Followup
Report Date 07/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberMS9557
Device Lot Number1406D01
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/01/2021
Date Manufacturer Received07/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-