FDA Adverse Event Malfunction Summary report: N

SYNCHRON® SYSTEMS DIGOXIN (DIGN) REAGENT

MDR report key: 2874417 · Received December 14, 2012

Report

Report Number: 2050010-2012-00022
Event Type: Malfunction
Date Received: December 14, 2012
Date of Event: November 14, 2012
Report Date: November 15, 2012
Manufacturer: BECKMAN COULTER INC.
Product Code: KXT
PMA / PMN Number: K982935
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

PER CUSTOMER, THEY HAD BEEN HAVING TROUBLE WITH ERRATIC QC RESULTS WITH REAGENT LOT M103376. THIS LOT HAS BEEN IN USE SINCE (B)(6) 2012 REVIEW OF QC DATA PROVIDED BY THE CUSTOMER INDICATED SOME ERRATIC DATA POINTS BUT WITHIN THE CUSTOMER'S ESTABLISHED 2SD RANGE. NO SERVICE CALL WAS INITIATED OR REQUESTED. NO OTHER ANALYTES ARE IN QUESTION. THE CUSTOMER WAS SENT A NEWER LOT OF REAGENT (M108161) AND THE CUSTOMER INDICATED BETTER PERFORMANCE OVERALL. THE CAUSE OF THE EVENT APPEARED TO BE REAGENT LOT M103376. MDR#2050010-2012-00021 DOCUMENTS THE RESULTS GENERATED ON (B)(6) 2012.

Description of Event or Problem · 1

A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING 4 ERRONEOUSLY LOW DIGOXIN (DIGN) RESULTS OVER 2 DAYS GENERATED BY THEIR UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM USING DIGOXIN REAGENT LOT M103376. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND AMENDED REPORTS WERE SENT OUT LATER. THIS REPORT DOCUMENTS THE RESULTS GENERATED ON (B)(6) 2012 AND A SEPARATE REPORT HAS BEEN SUBMITTED TO DOCUMENT THE RESULTS GENERATED ON (B)(6) 2012. THERE WAS NO AFFECT TO PATIENTS WITH REGARD TO THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SYNCHRON® SYSTEMS DIGOXIN (DIGN) REAGENT	ENZYME IMMUNOASSAY, DIGOXIN	KXT	BECKMAN COULTER INC.	NA	M103376

Patients

Seq	Age	Sex	Outcome	Treatment
1	99 YR