FDA Adverse Event Malfunction Summary report: N

PRISM HIV O PLUS

MDR report key: 4889254 · Received July 2, 2015

Report

Report Number: 1415939-2015-00021
Event Type: Malfunction
Date Received: July 2, 2015
Date of Event: April 26, 2015
Report Date: June 4, 2015
Manufacturer: ABBOTT LABORATORIES
Product Code: MZF
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

FURTHER EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, IN-HOUSE TESTING, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF PRODUCT LABELING. A CLINICAL SPECIFICITY TESTING PROTOCOL WAS EXECUTED USING LOT 46284M500. TESTING MET THE ACCEPTANCE CRITERIA AND DETERMINED THE PRODUCT IS MEETING EXPECTED SPECIFICITY REQUIREMENTS AND ARE 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 OF THE ABBOTT PRISM HIV O PLUS, LIST NUMBER 3L68, LOT 46284M500 WAS IDENTIFIED.

Additional Manufacturer Narrative · 1

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

Description of Event or Problem · 1

THE CUSTOMER OBSERVED FALSELY ELEVATED (B)(6) RESULTS FOR MULTIPLE PATIENTS, DURING THE TIME FRAME OF (B)(6) 2015, WHILE USING THE PRISM (B)(6) O PLUS ASSAY. THE CUSTOMER INDICATED THE PATIENT SPECIMENS WERE NEGATIVE WHEN TESTED BY THE (B)(6) IFA AND NAT METHODS. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
430793	PRISM HIV O PLUS	HIV-1 AND HIV-2 ANTIBODIES	MZF	ABBOTT LABORATORIES		46284M500

Patients

Seq	Age	Sex	Outcome	Treatment
1				LN 06A36-11, SN (B)(4)\| LN 06A36-11, SN (B)(4)\| PRISM ANALYZER\| PRISM ANALYZER