FDA Adverse Event Malfunction Summary report: N

COULTER AC·T DIFF ANALYZER

MDR report key: 3900982 · Received June 30, 2014

Report

Report Number: 1061932-2014-01530
Event Type: Malfunction
Date Received: June 30, 2014
Date of Event: June 2, 2014
Report Date: June 2, 2014
Manufacturer: BECKMAN COULTER
Product Code: GKZ
PMA / PMN Number: K973634
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT. THE FSE OBSERVED A HOLE IN THE WASTE LINE TUBING AT THE Y-UNION CAUSING AN INCOMPLETE DRAINING OF THE BATHS. THE FSE CUT THE TUBING TO REMOVE THE HOLE AND RE-ATTACHED THE TUBING TO RESOLVE THE LEAK ISSUE AND LOW COUNTS ON QUALITY CONTROL (QC). THE FSE VERIFIED THE INSTRUMENT AND THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. (B)(4).

Description of Event or Problem · 1

THE CUSTOMER REPORTED OBTAINING LOW COUNTS ON QUALITY CONTROL (QC) FOR RED BLOOD CELL (RBC), WHITE BLOOD CELL (WBC), AND HEMOGLOBIN (HGB) ON ALL LEVELS; AND A FEW ML OF FLUID LEAKED FROM THE COULTER AC·T DIFF ANALYZER. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PPE CONSISTING OF LAB COAT, GLOVES, AND EYE PROTECTION AT THE TIME OF THE OCCURRENCE. A BECKMAN COULTER (BEC) CUSTOMER TECHNICAL SPECIALIST (CTS) HAD THE CUSTOMER CHANGED THE PUMP TUBING AND VERIFIED THE VACUUM ISOLATOR CHAMBER (VIC) BUT THE ISSUE REMAINED. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION WITH THIS EVENT. THERE WAS NO DEATH, INJURY, OR AFFECT TO USER OR TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
380474	COULTER AC·T DIFF ANALYZER	COUNTER, DIFFERENTIAL CELL	GKZ	BECKMAN COULTER	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1