FDA Adverse Event Malfunction Summary report: N

ARCHITECT TOTAL B-HCG REAGENT

MDR report key: 2072094 · Received April 28, 2011

Report

Report Number: 1415939-2011-00140
Event Type: Malfunction
Date Received: April 28, 2011
Report Date: January 15, 2009
Manufacturer: ABBOTT LABORATORIES
Product Code: DHA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: OTHER
Health Professional: N

Narratives

Additional Manufacturer Narrative · 1

INTERNAL IDENTIFIER(S): = (B)(4). THIS PRODUCT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LN 7K78, ARCHITECT TOTAL B-HCG, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LN 6C21, ARCHITECT TOTAL B-HCG. A PRODUCT DEFICIENCY HAS BEEN IDENTIFIED. WITH A UNIQUE COMBINATION OF INSTRUMENT AND REAGENT CONDITIONS, THERE IS A POTENTIAL FOR SAMPLE CARRYOVER WHICH CAN RESULT IN FALSELY ELEVATED B-HCG CONCENTRATIONS ON THE ARCHITECT I1000SR SYSTEM. NEGATIVE SAMPLES HAVE RETURNED BOTH POSITIVE AND GREY ZONE B-HCG RESULTS WHEN A HIGH CONCENTRATION B-HCG SAMPLE IS ASSESSED PRIOR TO THE NEGATIVE SAMPLE WITH ARCHITECT TOTAL B-HCG (LIST NUMBER 7K78/6C21) ON AN I1000SR INSTRUMENT WHICH ALSO UTILIZES THE ARCHITECT RUBELLA IGG (LIST NUMBER 6C17) ASSAY. FURTHER INVESTIGATION OF THIS QUALITY ISSUE WILL BE CONDUCTED. AN INVESTIGATION IS IN PROCESS.

Description of Event or Problem · 1

THE CUSTOMER STATED AN ARCHITECT I1000SR ANALYZER GENERATED FALSELY ELEVATED B-HCG RESULTS FOR ONE PATIENT SAMPLE. DATA WAS REVIEWED AND FOUND NOT TO AFFECT THE CLINICAL INTERPRETATION OR MEDICAL DECISION MAKING. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ARCHITECT TOTAL B-HCG REAGENT	FOR THE DETERMINATION OF BETA-HUMAN CHORIONIC GONADOTROPIN	DHA	ABBOTT LABORATORIES		67911JN00

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown		ARCH I1000SR LN 01L86-01 SN (B)(6)\| ARCHITECT I1000SR ANALYZER LIST NUMBER 1L86-01\| ARCHITECT I1000SR ANALYZER LIST NUMBER 1L86-01