MAUDE Adverse Event Report: BECKMAN COULTER COULTER ACT 5 DIFF WBC LYSE; PRODUCTS, RED-CELL LYSING PRODUCTS

Catalog Number 8547170

Device Problems High Test Results (2457); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/21/2014

Event Type  malfunction  

Event Description

The customer reported high cv (coefficient of variation) was obtained for the white blood cell (wbc) parameter when using the coulter act 5 diff cap pierce (cp).The customer performed troubleshooting by completing extended cleaning.The problem was not resolved and a beckman coulter field service engineer (fse) was sent to the customer's facility to evaluate the analyzer.The fse identified crystals / precipitate / particles in the act 5diff wbc lyse reagent.There was no report of erroneous test results reported out of the laboratory for this event.There was no death, injury or affect to user or patient treatment.

Manufacturer Narrative

On (b)(4) 2014, the field service engineer (fse) evaluated the instrument and identified the act5diff wbc lyse reagent showed crystal particles.The fse flushed the system and installed a fresh bottle of wbc lyse reagent and verified it was clear of any precipitate.The fse performed verification and validation, all within specification.(b)(4).

• Brand Name: COULTER ACT 5 DIFF WBC LYSE
• Type of Device: PRODUCTS, RED-CELL LYSING PRODUCTS
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th avenue; miami FL 33196
• Manufacturer Contact: dung nguyen ; 250 s kraemer blvd; brea, CA 92821 ; 7149614941
• MDR Report Key: 4097384
• MDR Text Key: 4840795
• Report Number: 1061932-2014-02354
• Device Sequence Number: 1
• Product Code: GGK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2015
• Device Catalogue Number: 8547170
• Device Lot Number: 19002B
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1