FDA Adverse Event Malfunction Summary report: N

ACCESS® 2 IMMUNOASSAY ANALYZER

MDR report key: 1830410 · Received September 10, 2010

Report

Report Number: 2122870-2010-00523
Event Type: Malfunction
Date Received: September 10, 2010
Date of Event: August 13, 2010
Report Date: September 10, 2010
Manufacturer: BECKMAN COULTER, INC.
Product Code: LGD
PMA / PMN Number: K922823/A007
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION WAS NOT SUPPLIED. QC ON (B)(4) 2010 AND (B)(4) 2010 WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES. A SYSTEM CHECK WAS PERFORMED ON (B)(4) 2010 AND MET SPECIFICATIONS. CUSTOMER PRODUCT LINE SUPPORT (CPLS) TESTED THE FOUR PATIENT SAMPLES AND TWO QC SAMPLES BUT COULD NOT REPRODUCE THE CUSTOMER'S RESULTS. THE PATIENT SAMPLES RESULTED AS NON REACTIVE AND THE QC SAMPLES RESULTED WITHIN THEIR RESPECTIVE ACCEPTABLE RANGES. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED. CPLS TESTED THE SAMPLES.

Description of Event or Problem · 1

A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUSLY REACTIVE TOXO IGG RESULTS ON 4 PATIENT SAMPLES GENERATED BY ACCESS 2 IMMUNOASSAY ANALYZER. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER INITIALLY OBTAINED NON REACTIVE RESULTS, BUT UPON REPEAT BOTH NON REACTIVE PATIENTS AND QC BECAME REACTIVE. THE RESULTS WERE NOT PROVIDED. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF DEATH, INJURY REQUIRING MEDICAL INTERVENTION, OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR IN CONNECTION WITH THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ACCESS® 2 IMMUNOASSAY ANALYZER	DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER	LGD	BECKMAN COULTER, INC.	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1