FDA Adverse Event Malfunction Summary report: N

AXSYM DIGOXIN III

MDR report key: 1010003 · Received May 11, 2007

Report

Report Number: 2623532-2007-00049
Event Type: Malfunction
Date Received: May 11, 2007
Date of Event: February 27, 2007
Report Date: April 11, 2007
Manufacturer: ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.
Product Code: KXT
PMA / PMN Number: K061249
Removal / Correction Number: 2623532-4/10/07-003-C
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

Description of Event or Problem · 1

CUSTOMER STATED THAT ERROR CODES WERE GENERATED ON THREE PT SAMPLES WHILE PERFORMING CORRELATION STUDIES ON AXSYM DIGOXIN III ASSAY, LOT # 42722Q100. CUSTOMER STATED THAT NO ERROR CODES WERE GENERATED USING DIGOXIN II ASSAY. CUSTOMER PROVIDED THE RESULTS ON THREE PT SAMPLES THAT GENERATED THE ERROR CODES: DIGOXIN II: PT 1) 0.5, PT 2) 1.8, PT 3) 1.9. DIGOXIN III: ERROR CODE 1063, ERROR CODE 1062, ERROR CODE 1113. ERROR CODES: 1063 (INVALID TEST RESULT, CORRELATION COEFFICIENT TOO LOW), 1062 (INVALID TEST RESULT, READ PRECISION (#)), 1113 (INVALID TEST RESULT, READ VALUE (#)). CUSTOMER SENT SPECIMENS OUT TO A REFERENCE LAB. NO IMPACT TO PT MANAGEMENT REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	AXSYM DIGOXIN III	MEIA FOR THE MEASUREMENT OF DIGOXIN	KXT	ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.	NA	42722Q100

Patients

Seq	Age	Sex	Outcome	Treatment
1	NI			AXSYM ANALYZER LIST # 7A83-95