• 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 Physical Resistance/Sticking (4012)
Patient Problem Hypoglycemia (1912)
Event Date 05/18/2021
Event Type  Injury  
Manufacturer Narrative
Narrative field; new updated and corrected information is referenced within the update statements. Please refer to statement dated 09jun2021. No further follow up is planned. Evaluation summary: a female patient reported that the injection button of her humapen ergo ii device could be pressed down but the injection screw did not move. Insulin was not injected, so she took medicine orally. She experienced hypoglycemia. The device was not returned to the manufacturer for investigation (batch 1607d01, manufactured july 2016). Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction. Malfunction unknown. A batch threshold review did not identify any atypical findings with regard to injection screw not moving issues. All humapen ergo ii devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality 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 complaint: (b)(4). This solicited case reported by a consumer via patient support program (psp), concerned a female patient with unknown age and origin. Medical history and concomitant medication were unknown. The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injection (humalog mix 25) from cartridge via a reusable humapen (ergo ii, blue), at unknown dose and frequency, subcutaneously, for the treatment of type 1 diabetes mellitus, beginning around 2019. Around (b)(6) 2021, while on insulin lispro protamine suspension 75%/insulin lispro 25% therapy, the injection button of the humapen could be pressed down but the black injection screw did not move (pc number: (b)(4)/ lot 1607d01). The insulin lispro was not injected into, so she took medicine orally, and the blood sugar measured was 30-40, she never had this kind of situation, she felt that she could not live and she discontinued insulin lispro therapy around (b)(6) 2021. In morning of (b)(6) 2021, she did not eat, it was not good to eat. As soon as she ate, her blood sugar went up. She was very hungry, and often had hypoglycemia, her hands were also shaking and she felt that she was going to faint. On an unknown date, her blood sugar was extremely high (units, value and reference range were not provided). The event of hypoglycemia was considered serious by the company due to its medical significance. Information regarding any further corrective treatment and outcome of the events was not provided. Insulin lispro protamine suspension 75%/insulin lispro 25% therapy status after discontinuation was unknown. No additional follow-up would be attempted as the reporter refused to be followed up via phone and the contact details of treating physician was not provided. The patient was the operator of humapen and her training status was not provided. The general humapen model duration of use and the suspect humapen duration of use was approximately two years (since it was started around 2019). The action taken with the suspect humapen was unknown and it was not returned to the manufacturer. The reporting consumer assessed the relatedness between the events and insulin lispro protamine suspension 75%/insulin lispro 25% drug as unknown while did not provide an assessment of relatedness between the events and humapen ergo ii device. Edit 28may2021: updated medwatch and european (b)(6) fields for expedited device reporting. No new information added. Update 09jun2021: additional information received on (b)(6) 2021 from the global product complaint database. Entered the device specific safety summary (dsss). Updated the medwatch and european (b)(6) device fields. Added the date of manufacture for the suspect device associated with pc (b)(4). Corresponding fields and narrative updated accordingly. Edit 15-jun-2021: upon internal review of the information received on (b)(6) 2021, updated formulation of suspect product to reflect cartridge from unknown and updated the relevant fields accordingly. No other changes were made to the case.
 
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)
TECH GROUP NORTH AMERICA INC. DBA WEST
640 south rockford drive
tempe AZ 85281
Manufacturer Contact
chris davis
lilly corporate center
indianapolis, IN 46285
3174334585
MDR Report Key12052564
MDR Text Key268070543
Report Number1819470-2021-00078
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
Report Date 06/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMS9557
Device Lot Number1607D01
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2016
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: 06/23/2021 Patient Sequence Number: 1
-
-