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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 Mechanical Problem (1384)
Patient Problem No Code Available (3191)
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 spontaneous case, reported by a consumer who contacted the company to report adverse events along with product complaint, concerned a (b)(6) male patient of asian ethnicity. Medical history was not provided. Concomitant medications included insulin glargine for unknown indication. The patient received insulin lispro (rdna origin) (humalog, 100 iu/ml cartridge) via unknown reusable device (humapen unknown), three times daily (10 units in morning, 15 units in noon, 15 units in night) from unknown route for the treatment of diabetes mellitus beginning on an unknown date in 2000. On an unknown date after starting insulin lispro therapy, as the insulin lispro dosage was inaccurate (needed to inject 11 units but injected only 8 units) due to device issue ((b)(4)/ batch number- unknown), he was hospitalized to get his blood glucose adjusted (values and reference range not provided). More information regarding laboratory tests and hospitalization details was not provided. Corrective treatment and outcome of the events was not provided. Status of insulin lispro therapy was ongoing. The operator of the humapen was patient and his training status was not provided. The general and suspect humapen model duration of use was not provided as it was started on an unknown date in 2008. The action taken and return status with respect to suspect humapen was not provided. The reporting consumer was not sure whether the events were related to insulin lispro therapy or not. The reporting consumer did not provide relatedness assessment between the events and humapen device. Edit 26jul2018: 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 Key7758831
MDR Text Key116391307
Report Number1819470-2018-00128
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 09/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2018
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?
Event Location No Information
Date Manufacturer Received08/22/2018
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: 08/07/2018 Patient Sequence Number: 1
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