FDA Adverse Event Injury Summary report: N

CELL-DYN SAPPHIRE ANALYZER

MDR report key: 1760173 · Received July 16, 2010

Report

Report Number: 2919069-2010-00347
Event Type: Injury
Date Received: July 16, 2010
Date of Event: June 24, 2010
Report Date: June 24, 2010
Manufacturer: ABBOTT DIAGNOSTICS DIVISION
Product Code: GKZ
PMA / PMN Number: K051215
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TU
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B) (4) A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION.THE CELL-DYN SAPPHIRE SYSTEM OPERATOR'S MANUAL, LIST NUMBER 08H10-01, REVISION A, CONTAINS INFORMATION TO ADDRESS THE ISSUE CURRENTLY UNDER EVALUATION. SECTIONS 8 AND 9 DESCRIBE THE USE OF PERSONAL PROTECTIVE EQUIPMENT AND FOLLOWING OF BIOSAFETY PRACTICES. CONTROLS IN PLACE TO REDUCE THE RISK ARE ROUNDED OR SQUARED CORNERS AND DRAWINGS SPECIFYING THAT EDGES SHOULD BE BLUNTED. BASED ON THE INVESTIGATION, NO PRODUCT MALFUNCTION WAS IDENTIFIED FOR THE CELL-DYN SAPPHIRE RELATED TO THE REPORTED ISSUE.

Description of Event or Problem · 1

AN ABBOTT FIELD SERVICE ENGINEER (FSE) WAS AT THE CUSTOMER SITE INSTALLING A DILUENT SUPPLY UPGRADE KIT TO THE CELL-DYN SAPPHIRE ANALYZER. DURING THE INSTALLATION, HE CUT HIS FINGER ON A RUSTED METAL CONNECTOR. THE FSE WAS WEARING GLOVES AT THE TIME, BUT THE CONNECTOR TORE THE GLOVE AND CAUSED HIS FINGER TO BLEED. THE FSE RINSED THE FINGER IN TAP WATER AND WENT TO THE EMERGENCY DEPARTMENT WHERE HE WAS GIVEN A TETANUS SHOT AND HAD THE FINGER BANDAGED. THE FSE IS NOW BACK AT WORK AND DOING FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CELL-DYN SAPPHIRE ANALYZER	AUTOMATED HEMATOLOGY ANALYZER	GKZ	ABBOTT DIAGNOSTICS DIVISION

Patients

Seq	Age	Sex	Outcome	Treatment
1	33 YR		Required Intervention