ARCHITECT CA 19-9XR

MDR report key: 2835067 · Received November 16, 2012

Report

Report Number: 1415939-2012-02078
Event Type: Malfunction
Date Received: November 16, 2012
Date of Event: October 30, 2012
Report Date: November 1, 2012
Manufacturer: ABBOTT LABORATORIES
Product Code: NIG
PMA / PMN Number: K052000
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Additional Manufacturer Narrative · 1

FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, IN-HOUSE TESTING, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. THE CUSTOMER INDICATED THAT THE ISSUE WAS DUE TO THE STORAGE AND HANDLING OF THE SAMPLE. AN ACCURACY TESTING PROTOCOL WAS EXECUTED USING LOT 14780M500; TESTING MET THE ACCEPTANCE CRITERIA AND DETERMINED THE REAGENT IS PERFORMING ACCEPTABLY. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY AND NO MALFUNCTION OF THE ARCHITECT CA19-9XR REAGENT LIST NUMBER 02K91, LOT NUMBER 14780M500, WAS IDENTIFIED.

Description of Event or Problem · 1

THE CUSTOMER OBSERVED FALSELY ELEVATED CA19-9 RESULTS WHILE USING THE ARCHITECT CA19-9XR ASSAY. THE CUSTOMER PROVIDED THE FOLLOWING RESULTS (IU/ML ) FOR A PROSTATE CANCER PATIENT: (B)(6) 2012: 462; (B)(6) 2012: 16.9; (B)(6) 2012: 23.2; (B)(6) 2012: INITIAL 1010.5, RETEST 1044.03. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED. NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ARCHITECT CA 19-9XR		NIG	ABBOTT LABORATORIES		14780M500

Patients

Seq	Age	Sex	Outcome	Treatment
1				LN 01L86-01, SN (B)(4)\| ARCHITECT I1000SR ANALYZER\| LN 01L86-01, SN (B)(4)\| ARCHITECT I1000SR ANALYZER