MAUDE Adverse Event Report: BECKMAN COULTER COULTER LH 750 HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL

Catalog Number	6605632
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	09/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The fse found that the high wbc and rbc cv's were caused by a faulty aspiration pump, pm9.The fse replaced the faulty aspiration pump which resolved the high cv's and the instrument ran without leaks and all repairs were verified per established service procedure.(b)(4).
Event or Problem Description
While a field service engineer (fse) was troubleshooting an unrelated event, the fse found high wbc (white blood cell) and rbc (red blood cell) cv's (coefficient of variation) on the coulter lh 750 hematology analyzer.Erroneous patient results were not generated and there was no change or affect to patient treatment in connection to the event.There was no impact to patient results and controls.
Additional Manufacturer Narrative
The catalog number provided in the initial report was found to be incorrect; the corrected number is provided in this follow-up report.

• Brand Name: COULTER LH 750 HEMATOLOGY ANALYZER
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s kraemer blvd; brea CA 92821
• MDR Report Key: 6034326
• Report Number: 1061932-2016-00892
• Device Sequence Number: 16253564
• Product Code: GKZ
• UDI-Device Identifier: 15099590264772
• UDI-Public: (01)15099590264772(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K061574
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2016

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
• Operator of Device: Health Professional
• Device Catalogue Number: 6605632
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/17/2016
• Supplement Report FDA Received Date: 11/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1