FDA Adverse Event Other Summary report: N

INPECO SYSTEM

MDR report key: 927838 · Received October 16, 2007

Report

Report Number
1628664-2007-00453
Event Type
Other
Date Received
October 16, 2007
Report Date
September 21, 2007
Manufacturer
ABBOTT MANUFACTURING, INC.
Product Code
JQW
PMA / PMN Number
EXEMPT
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
UK
Reporter Occupation
UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

INVESTIGATION IS IN PROCESS, NO CODES CAN BE DETERMINED AT THIS TIME. AN INVESTIGATION IS IN PROGRESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

Description of Event or Problem · 1

THE OPERATOR RECEIVED A CUT BETWEEN THE THUMB AND THE PALM OF HER HAND FROM A METAL BRACKET NEAR THE DECAPPER ON THE INPECO SYSTEM WHEN REMOVING SAMPLES FROM THE TRACK AREA. THE OPERATOR WASHED HER HAND AND PUT A BAND-AID ON THE CUT. NO FURTHER MEDICAL TREATMENT WAS OBTAINED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 INPECO SYSTEM AUTOMATED SAMPLE HANDLING AND PROCESSING SYSTEM JQW ABBOTT MANUFACTURING, INC. NA NA

Patients

Seq Age Sex Outcome Treatment
1 YR