FDA Adverse Event Malfunction Summary report: N

ACCESS® 2 IMMUNOASSAY SYSTEM

MDR report key: 2230159 · Received September 1, 2011

Report

Report Number: 2122870-2011-03178
Event Type: Malfunction
Date Received: September 1, 2011
Date of Event: August 3, 2011
Report Date: August 3, 2011
Manufacturer: BECKMAN COULTER, INC.
Product Code: MMI
PMA / PMN Number: K922823/A007
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OR, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

SAMPLE COLLECTION AND SPECIFIC CENTRIFUGATION DATA WAS NOT SUPPLIED. THE LABORATORY HAS AN ACCUTNI PATIENT SAMPLE REPEAT ANALYSIS PROCEDURE, WHICH INCLUDES REPEATING ALL ACCUTNI SAMPLES OUTSIDE LABORATORY'S NORMAL REFERENCE RANGE PRIOR TO REPORTING RESULTS. REPEAT ANALYSIS PROTOCOL AND CRITERIA WAS NOT SUPPLIED. NO SPECIFIC EVENT QC DATA WAS SUPPLIED. THE INSTRUMENT IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS UPON CONTACT WITH THE CUSTOMER. THE CUSTOMER DID NOT PROVIDE INFORMATION INDICATING AN INCREASE IN OCCURRENCE OR AN INSTRUMENT MALFUNCTION. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. A ROOT CAUSE FOR THIS EVENT WAS NOT DETERMINED.

Description of Event or Problem · 1

A CUSTOMER WAS CONTACTED BY BECKMAN COULTER, INC. (BEC) REGARDING ACCUTNI ASSAY PERFORMANCE AND INDICATED SOME OCCURRENCES OF NON-REPRODUCIBLE FALSE POSITIVE TROPONIN (ACCUTNI) RESULTS GENERATED BY ACCESS 2 IMMUNOASSAY SYSTEM. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE PERTINENT DATA WERE NOT PROVIDED. THE CUSTOMER DID NOT REPORT EFFECT TO PATIENTS OR USER ATTRIBUTED OR CONNECTED TO THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ACCESS® 2 IMMUNOASSAY SYSTEM	ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE	MMI	BECKMAN COULTER, INC.	ACCESS 2	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1