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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN ERGO II FOR TREATMENT PURPOSES

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ELI LILLY AND COMPANY HUMAPEN ERGO II FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9557
Device Problem Failure to Infuse (2340)
Patient Problems Hyperglycemia (1905); Thrombosis (2100)
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 report will be submitted when the final evaluation has been completed.
 
Event Description
(b)(4). This spontaneous case, reported by a pharmacist who contacted the company to report adverse event, with product complaint (pc), concerned a patient of unspecified gender, age and origin. Medical history, previous drug adverse reaction, family drug adverse reaction and concomitant medication were not provided. The patient received insulin lispro (rdna origin) injections (humalog, unspecified type) via a cartridge via reusable pen (humapen ergo ii), at an unknown dose and frequency subcutaneously for the treatment of diabetes mellitus beginning on an unknown date. The patient start using humapen ergo ii from (b)(6) 2019. Since an unknown date, the patient could not inject insulin with the injection pen, the dosage of insulin in the cartridge did not decrease at all, the pharmacy did not known the dose display unit return to zero or not (pc: 4690741, lot number: 1706d01). And the patients blood glucose rise, and cerebral thrombosis occurred. Event of blood glucose increased and cerebral thrombosis were considered as serious due to medical significant. Information regarding corrective treatment, outcome of the events and therapy status of insulin lispro and humapen ergo ii was not provided. The user of humapen ergo ii and his/her training status was not provided. The humapen ergo ii duration of use was not provided but it was started on (b)(6) 2019. The suspect humapen ergo ii duration of use was not provided and its return was not expected. The reporting pharmacist did not provide an opinion of relatedness between the events and treatment with insulin lispro and humapen ergo ii. Edit 16apr2019: updated medwatch and european and (b)(4) fields for expedited device reporting. No new information added.
 
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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)
PHILLIPS-MEDISIZE CORPORATION
415 red cedar street
medical device manufacturing
menomonie WI 54751
Manufacturer Contact
chris davis
lilly corporate center
indianapolis, IN 46285
3174334585
MDR Report Key8560496
MDR Text Key143538743
Report Number1819470-2019-00070
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 foreign,health professional
Type of Report Initial,Followup
Report Date 06/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS9557
Device Lot Number1706D01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/10/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/30/2017
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: 04/29/2019 Patient Sequence Number: 1
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