FDA Adverse Event Malfunction Summary report: N

ARCHITECT HAVAB IGM

MDR report key: 3476036 · Received November 19, 2013

Report

Report Number: 3002809144-2013-00192
Event Type: Malfunction
Date Received: November 19, 2013
Report Date: October 30, 2013
Manufacturer: ABBOTT GERMANY
Product Code: LOL
PMA / PMN Number: K063329
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KS
Reporter Occupation: HEALTH PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 1

(B)(4). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST 06C30 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE U.S., LIST NUMBER 06L21.

Description of Event or Problem · 1

THE CUSTOMER OBSERVED (B)(6) ARCHITECT HAVAB IGM RESULTS WHILE USING THE ARCHITECT HAVAB IGM ASSAY. THE CUSTOMER INDICATED THEY DIVIDED ONE PATIENT SPECIMEN AND SENT EACH HALF TO 2 DIFFERENT LABORATORIES. THE ARCHITECT RESULTS (SCL LAB) WERE DEEMED DISCREPANT COMPARED TO THE RESULTS GENERATED BY THE ROCHE ASSAY (EONE LAB), AS FOLLOWS: SAMPLE 1: ARCHITECT (SCL LAB): (B)(6). THIS SPECIMEN WAS THEN SENT TO THE EONE LAB AND TESTED BY ROCHE GENERATING A (B)(6) RESULT. SAMPLE 2: ROCHE RESULT (EONE LAB): (B)(6). THIS SPECIMEN WAS THEN SENT TO THE SCL LAB AND TESTED USING THE ARCHITECT HAVAB IGM ASSAY AND WAS (B)(6). A NEW SPECIMEN WAS COLLECTED AND TESTED AT THE SCL LAB AND GENERATED (B)(6) ARCHITECT HAVAB IGM RESULTS: (B)(6). A BIOCHEMICAL ASSAY WAS ALSO TESTED (AST 1885/ ALT 1480) SUPPORTING THIS PATIENT BEING (B)(6). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
600333	ARCHITECT HAVAB IGM		LOL	ABBOTT GERMANY		31170LI00

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown		LN 03M74-02, SN (B)(4)\| ARCHITECT I2000SR ANALYZER