MAUDE Adverse Event Report: BECKMAN COULTER COULTER LH 780 HEMATOLOGY ANALYZER

Catalog Number 723585

Device Problem Output Problem (3005)

Patient Problem Missing Value Reason (3192)

Event Date 12/05/2015

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) evaluated the instrument on (b)(4) 2015.The fse confirmed what the customer had reported regarding the 5c controls that were failing on diff parameters.He checked the diff pumps for proper operation and noticed the diff preserve pump (pm1, stabilise pump) was not delivering reagent properly and replaced this pump.The repairs were verified per established service procedures.(b)(4).

Event Description

The customer reported their coulter lh 780 hematology analyzer gave intermittent differential (diff) incompletes (non-numeric replacement codes) and high monos on control samples, there was no death, injury, or change to patient treatment and no erroneous results were generated in connection with the reported event.

• Brand Name: COULTER LH 780 HEMATOLOGY ANALYZER
• Type of Device: COULTER LH 780 HEMATOLOGY ANALYZER
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER, INC.; 11800 sw 147th avenue; miami FL 33196 2031
• Manufacturer Contact: miranda holland ; 11800 sw 147th avenue, 32-s08; miami, FL 33196-2031 ; 3053802031
• MDR Report Key: 5330731
• MDR Text Key: 34524936
• Report Number: 1061932-2015-01885
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 723585
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2015
• Initial Date FDA Received: 12/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2012
• 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