FDA Adverse Event Malfunction Summary report: N

ACT+ CUVETTE ASSAY (HEMOCHRON ELITE SYSTEM)

MDR report key: 2573027 · Received May 9, 2012

Report

Report Number: 2248721-2012-00051
Event Type: Malfunction
Date Received: May 9, 2012
Date of Event: April 11, 2012
Report Date: April 12, 2012
Manufacturer: INTERNATIONAL TECHNIDYNE CORP.
Product Code: JBP
PMA / PMN Number: K941007
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NC, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). CUSTOMER TESTED USING INSTRUMENT SERIAL NUMBERS (B)(4). ACTUAL DEVICE NOT EVALUATED. PROCESS EVALUATION PERFORMED. CUVETTE DEVICE HISTORY RECORDS REVIEWED AND FOUND TO MEET SPECIFICATIONS. NO RELATED NCMRS, COMPLAINT TRENDS, OR CAPA IDENTIFIED.

Description of Event or Problem · 1

HEALTHCARE PROFESSIONAL REPORTS UNEXPECTED ACT+ RESULTS WITH HEMOCHRON ELITE MICROCOAGULATION SYSTEM DURING VASCULAR SURGERY APPLICATION (RIGHT LOWER EXTREMITY-DISTAL BYPASS). NO BASELINE TEST WAS PERFORMED. TARGET DISTAL RAGE WAS 250-350 SECONDS. POST-ADMINISTRATION OF HEPARIN ELITE INSTRUMENT (B)(4) GENERATED LOWER THAN EXPECTED ACT+ RESULTS OF 165 SECONDS AND 171 SECONDS. COMPARISON TESTING PERFORMED ON A SECOND ELITE INSTRUMENT (B)(4) GENERATED INCONSISTENT RESULTS OF 520 SECONDS AND REPEAT TEST OF 190 SECONDS. AN HOUR AFTER THE LAST DOSE OF HEPARIN, SIDE BY SIDE CORRELATION TESTING WAS PERFORMED AND DEMONSTRATED VARIABILITY BETWEEN INSTRUMENTS. ELITE (B)(4) GENERATED 134 SECONDS AND ELITE (B)(4) GENERATED 166 SECONDS. TARGET RAGE: 250-350 SECONDS. NO ADVERSE EVENT(S) REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ACT+ CUVETTE ASSAY (HEMOCHRON ELITE SYSTEM)		JBP	INTERNATIONAL TECHNIDYNE CORP.	JACT+	B2JAC069

Patients

Seq	Age	Sex	Outcome	Treatment
1	65 YR