MAUDE Adverse Event Report: BECKMAN COULTER COULTER LH 780 HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL

Catalog Number 723585

Device Problems Leak/Splash (1354); Output Problem (3005)

Patient Problem Test Result (2695)

Event Date 08/28/2016

Event Type  malfunction  

Manufacturer Narrative

The customer reported erroneously low hgb, mean corpuscular hemoglobin (mch), and mean corpuscular hemoglobin concentration (mchc) results for three patient samples cycled on the lh780.One patient sample recovered with vote outs for the hgb, mch, and mchc.The customer also reported an uncontained leak.The leak was estimated to be between 200 and 300 mls.There were no error messages reported at the time of the event.The field service engineer (fse) was at the customer site and observed the valve at vl4 was broken causing the leak and low and voted out hgb, mch and mcv results.The fse replaced vl4 resolving the issues.The repairs were verified per established procedures.(b)(4).

Event Description

The customer reported erroneously low hgb, mean corpuscular hemoglobin (mch), and mean corpuscular hemoglobin concentration (mchc) results for three patient samples cycled on their coulter lh 780 hematology analyzer.One patient sample recovered with vote outs for the hgb, mch, and mchc.The customer also reported an uncontained leak.The leak was estimated to be between 200 and 300 mls.No erroneous results were reported out of the lab and there was no change or effect to patient treatment in connection with this event.The customer was wearing personal protective equipment (ppe) consisting of laboratory coat and gloves at the time of the event and there was no report of injury or biohazard exposure to open wounds or mucous membranes.

• Brand Name: COULTER LH 780 HEMATOLOGY ANALYZER
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 250 s. kraemer blvd; brea CA 92821
• Manufacturer Contact: miranda holland ; 11800 sw 147th avenue, 32-s08; miami, FL 33196-2031 ; 3053802031
• MDR Report Key: 5970191
• MDR Text Key: 55451580
• Report Number: 1061932-2016-00826
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K061616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 723585
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2008
• 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