FDA Adverse Event Malfunction Summary report: N

COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

MDR report key: 1806468 · Received August 18, 2010

Report

Report Number: 1061932-2010-00118
Event Type: Malfunction
Date Received: August 18, 2010
Date of Event: July 19, 2010
Report Date: August 18, 2010
Manufacturer: BECKMAN COULTER INC.
Product Code: GKZ
PMA / PMN Number: K010765
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: WA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CONTROLS ARE RUN PER SHIFT AND WERE WITHIN ESTABLISHED RANGES PRE AND POST THE EVENT. ON (B)(6) 2010, LH SERIES PAK WAS REPLACED WITH A DIFFERENT LOT AND 5C ABNORMAL II CONTROL ISSUE WAS RESOLVED. A BCI FIELD SERVICE ENGINEER (FSE) DISCOVERED A LEAK ABOVE THE PUMP MODULE. FSE REPLACED PARTS ON THE UNIT AND VERIFIED DIFFERENTIAL CHEMISTRY. A CLEAR ROOT CAUSE CAN NOT BE DETERMINED FOR THIS EVENT.

Description of Event or Problem · 1

A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY HIGH MONOCYTES (MO%) AND NEUTROPHILE (NE%) RESULTS WITH BLASTS, IMM GRAN, AND VARIANT LYMPH SUSPECT FLAGS GENERATED BY THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. HMX SAMPLE RESULTS DID NOT CORRELATE TO MANUAL SMEAR AND DXH 800 INSTRUMENT RESULTS WHICH WERE CONSIDERED CORRECT. MANUAL SMEAR RESULTS ARE NOT AVAILABLE. THE CUSTOMER REPLACED LH700 SERIES PAK REAGENT ON HMX AND THE RESULT SHOWED CORRECT DIFFERENTIAL RESULT. RESULTS FOR THREE (3) SAMPLES FROM ALTERNATE UNIT SHOWED DIFFERENTIAL RESULTS WHICH THE LAB CONSIDERED CORRECT. PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER	HEMATOLOGY ANALYZER,	GKZ	BECKMAN COULTER INC.	N/A	N/A

Patients

Seq	Age	Sex	Outcome	Treatment
1