MAUDE Adverse Event Report: BECKMAN COULTER COULTER LH 750 HEMATOLOGY ANALYZER

Catalog Number 6605632

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2015

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) was dispatched on (b)(4) 2015.The fse found intermittent high rbc on manual mode only compared to automatic mode and parts were ordered.Automatic mode was verified and validated.Another fse returned and replaced the bsv (blood sampling valve) to address the reported issues and adjusted the rbc, hgb, and mcv calibration using the normal control.The instrument ran without further issues and all repairs were verified per established service procedures.(b)(4).

Event Description

The customer reported they performed a mode to mode comparison (manual mode to auto mode) on the coulter lh 750 hematology analyzer, red blood count (rbc) did not match and h&h (hemoglobin and hematocrit) check failed.The customer stated mode to mode ran earlier was okay and now preferred not to troubleshoot and requested service.There was no death, injury, or change to patient treatment and no report erroneous results were generated in connection with the reported event.

• Brand Name: COULTER LH 750 HEMATOLOGY ANALYZER
• Type of Device: COULTER LH 750 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: 5316983
• MDR Text Key: 34081582
• Report Number: 1061932-2015-01865
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061574
• 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: 11/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 6605632
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2011
• 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