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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN, UNKNOWN DEVICE FOR TREATMENT PURPOSES

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ELI LILLY AND COMPANY HUMAPEN, UNKNOWN DEVICE FOR TREATMENT PURPOSES Back to Search Results
Model Number UNKNOWN
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)
Event Date 01/31/2015
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. This report is associated with 1819470-2018-00107 since there is more than one device implicated. The humapen luxura (burgundy) device was associated with an abnormal unstable blood sugar on an unknown date in 2015 and the humapen (unknown body type) device was associated with an unstable blood glucose on an unknown date in (b)(6) 2018.
 
Event Description
(b)(4). This report is associated with product complaint: pending. This spontaneous case, reported by a consumer who contacted the company to report adverse events and product complaint, concerned a (b)(6) asian female patient of han nationality. Medical history included fundus hemorrhage. Concomitant medication was not provided. The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) (humalog mix 50) via 3 ml: 300 units/cartridge via unknown humapen at a dose of 14 units in the morning and 12 units in the night (bid) subcutaneously for the treatment of diabetes mellitus beginning on sometimes in 2015. On an unknown date in 2015, after started on insulin lispro protamine suspension 50%/insulin lispro 50% therapy, she was hospitalized due to the event of unstable blood glucose. Approximately in (b)(6) 2018, she could not inject in while injection and the patient was admitted to the hospital due to the event of unstable blood glucose ((b)(4); lot 1112b05 and (b)(4); lot unknown). Corrective treatment was not provided. Outcome of the events was unknown. Status of insulin lispro protamine suspension 50%/insulin lispro 50% was continued. The operator of the device unknown humapen and hp luxura pen was patient and her training status was not provided. The unknown humapen model duration of use was not provided but it started on sometimes in 2015. The reported unknown humapen duration of use was not provided. The action taken with the unknown humapen and its return status were not provided. The hp luxura model duration of use was not provided but it started in 2010. The reported hp luxura pen duration of use was not provided. The action taken with the hp luxura pen and its return status were not provided. The reporting consumer did not know if the events were related to insulin lispro protamine suspension 50%/insulin lispro 50% therapy or unknown humapen and hp luxura pen. Edit 14jun2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting. No new information added. Edit 14jun2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting. No new information added. Edit 15-jun-2018: upon internal review for the information received 12-jun-2018. Changed suspect device coding from humapen ergo to unknown humapen. Added device causality as device nhcp for the event of ddo on hp luxura device. Updated narrative with pc number. Edit 21jun2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting. No new information added.
 
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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
chris davis
lilly corporate center
indianapolis, IN 46285
3174334585
MDR Report Key7638533
MDR Text Key112377888
Report Number1819470-2018-00106
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 consumer,foreign
Type of Report Initial,Followup
Report Date 07/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/03/2018
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: 06/26/2018 Patient Sequence Number: 1
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