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Adverse Event Report

ELI LILLY AND CO. HUMAPEN ERGO, TEAL/OPAQUE PEN INJECTOR   back to search results
Model Number MS8335
Event Type  Injury   Patient Outcome  Hospitalization;
Event Description

This device case, which involves an adverse event, reported by a sales rep, concerns a pt who experienced ketosis. The pt was taking an unspecified medicatiion via a humapen ergo device for treatment of diabetes. The device was operated by the consumer. It is unknown if the consumer was a trained user or how long they had used the device for. The pt's medical history and concomitant medications are unknwon. In jan-2002, after beginning an unspecified drug via the humapen ergo (ms8335/model number unknown, lot number a1409), the pt found that the lead screw of the humapen did not work very well (always one week after beginning using the humapen, the pt's family member found the volume of insulin in the cartridge was just the same as the week before. The pt was diagnosed with ketosis and later hospitalized. No other information was provided. It is unknown if the unspecified drug was continued or discontinued. It is also unknown if use of the humapen ergo was continued or discontinued. The pt outcome is unknown. This case is unassessed for causality as the reporter was not a health care preofessional. A preliminary report has not been provided. No further information is available.

 
Manufacturer Narrative

Device evaluation anticipated, but not yet begun.

 
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Brand NameHUMAPEN ERGO, TEAL/OPAQUE
Type of DevicePEN INJECTOR
Baseline Brand NameHUMAPEN ERGO 3ML
Baseline Generic NamePEN INJECTOR
Baseline Catalogue NumberNI
Baseline Model NumberMS8335
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
ELI LILLY AND CO.
lilly corporate center
indianapolis IN 46285
Manufacturer (Section D)
ELI LILLY AND CO.
lilly corporate center
indianapolis IN 46285
Manufacturer Contact
lilly corporate center
indianapolis , IN 46285
(317) 276 -7788
Device Event Key373282
MDR Report Key384232
Event Key362766
Report Number1819470-2002-00009
Device Sequence Number1
Product CodeKZE
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 02/27/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/21/2002
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device MODEL NumberMS8335
Device LOT NumberA1409
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/27/2002
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Database last updated on December 31, 2008

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