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Adverse Event Report

ELI LILLY AND CO. HUMAPEN ERGO, TEAL/CLEAR PEN INJECTOR   back to search results
Model Number MS8929
Event Type  Malfunction  
Event Description

The patient was taking an unspecified medication via a humapen ergo teal/clear pen body with a clear cartridge holder attached for an unknown indication. The person operating the device was the patient. It is unknown if the operater of the device was trained. The device was returned to the company. Initial analysis by the affiliate quality control deparment found: pen had detached footpad. The investigation confirmed a detached footpad. The investigation also found two broken clear cartridge holder engagement tabs and a needle sheath stuck in the cap. The product is out of specification for dose accuracy. Two tab breakage has been shown to deliver an underdose of insulin. The device is being returned to the manufacturer for additional evaluation. Final analysis found the complaint device was returned in a condition that was not possible to test as both cartridge holder engagement tabs were broken and foot detached, which may lead to a possible underdose. No other defects were identified. There is evidence of improper use/storage. Removal of clear cartridge holder engagement tabs indicates improper use/storge (possible underdose). The needle sheath stuck in cap also indicates improper use (no dosing issue).

 
Manufacturer Narrative

Two broken engagement tabs were identified. The product is out of specification for dose accuracy. Two tab breakage has been shown to result in an underdose of product. Final analysis found the complaint device was returned in a condition that was not possible to test as both cartridge holder engagement tabs were broken and foot detached, which may lead to a possible underdose. No other defects were identified. There is evidence of improper use/storage. Removal of clear cartridge holder engagement tabs indicates improper use/storage (possible underdose). The needle sheath stuck in cap also indicates improper use (no dosing issue).

 
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Brand NameHUMAPEN ERGO, TEAL/CLEAR
Type of DevicePEN INJECTOR
Baseline Brand NameHUMAPEN ERGO, TEAL/CLEAR
Baseline Generic NamePEN INJECTOR
Baseline Catalogue NumberNI
Baseline Model NumberMS8929
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 (Section G)
PHILLIPS. ORIGEN MEDICAL DEVICE MANUFACTURING
415 red cedar street
menomonie WI 54751
Manufacturer Contact
lilly corporate center
indianapolis , IN 46285
(317) 276 -7788
Device Event Key476903
MDR Report Key488048
Event Key462720
Report Number1819470-2003-00033
Device Sequence Number1
Product CodeFMF
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation NO INFORMATION
Type of Report Initial
Report Date 09/05/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/03/2003
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device MODEL NumberMS8929
Device LOT Number40204
OTHER Device ID NumberCID CID00193110
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/28/2003
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received09/12/2003
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on January 30, 2009

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