FDA Adverse Event Malfunction Summary report: N

CELL-DYN 1700 ANALYZER

MDR report key: 1873142 · Received October 18, 2010

Report

Report Number: 2919069-2010-00485
Event Type: Malfunction
Date Received: October 18, 2010
Report Date: September 21, 2010
Manufacturer: ABBOTT DIAGNOSTICS DIVISION
Product Code: GKZ
PMA / PMN Number: K870233
Removal / Correction Number: 2919069-3/31/09-002-C
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). AN EXPANDED INVESTIGATION THROUGH CORRECTION AND REMOVAL FA27SEP2010 WAS CONDUCTED TO EVALUATE THIS ISSUE. THE ROOT CAUSE IDENTIFIED FOR THIS ISSUE IS INSTALLATION OF THE INCORRECT FUSE BY EITHER THE CUSTOMER OR THE FIELD SERVICE REPRESENTATIVE. A PRODUCT CORRECTION LETTER WAS SENT TO THE CUSTOMERS ALONG WITH THE FUSE LABEL TO BE AFFIXED TO THE BACK OF THE INSTRUMENT INSTRUCTING THE CUSTOMER TO CHECK IF THE FUSE MATCHES THE VOLTAGE OF OPERATION AND TO INSTALL THE CORRECT FUSE (PROVIDED IN THE ACCESSORY KIT SHIPPED WITH THE ANALYZER) FOLLOWING REPLACEMENT INSTRUCTIONS PROVIDED IN THE LETTER. THE CUSTOMERS ARE ALSO INSTRUCTED TO ORDER THE CORRECT FUSE IF IT IS NOT PROVIDED IN THE ACCESSORY KIT.

Description of Event or Problem · 1

THE CUSTOMER STATED THAT THE CELL-DYN ANALYZER WENT OUT WITH NO ELECTRIC POWER REACHING THE INSTRUMENT. THE CUSTOMER VERIFIED THAT THE POWER OUTLET WAS WORKING AND RECONNECTED THE POWER CORD WITH NO RESOLUTION. THE CUSTOMER WAS INSTRUCTED TO CHECK THE POWER SUPPLY FUSE WHICH WAS INCORRECT AND WAS BURNED OUT. THE FUSE WAS REPLACED BY THE CORRECT ONE IN ORDER TO RESOLVE THE ISSUE. NO IMPACT TO PATIENT RESULTS, PATIENT MANAGEMENT OR USER SAFETY WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CELL-DYN 1700 ANALYZER	AUTOMATED HEMATOLOGY ANALYZER	GKZ	ABBOTT DIAGNOSTICS DIVISION

Patients

Seq	Age	Sex	Outcome	Treatment
1				POWER SUPPLY FUSE