MAUDE Adverse Event Report: BECKMAN COULTER COULTER LH780 HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL

Model Number	N/A
Medical Device Problem Code	Output above Specifications (1432)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	11/17/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 11/18/2016 the field service engineer (fse) found that the light scatter preamp (ls preamp) was defective causing the elevated counts and failed controls.The fse replaced the ls preamp and the instrument then ran within published specifications.The repairs were verified per established procedures.(b)(4).
Event or Problem Description
The customer reported that the lh780 analyzer generated erroneous high basophil (ba) counts for patient samples.Erroneous results were not reported out of the lab and there was no change or effect to patient treatment in connection with this event.

• Brand Name: COULTER LH780 HEMATOLOGY ANALYZER
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 south kraemer blvd.; brea CA 92821
• MDR Report Key: 6138926
• Report Number: 1061932-2016-00978
• Device Sequence Number: 11045150
• Product Code: GKZ
• UDI-Device Identifier: 15099590282431
• UDI-Public: (01)15099590282431(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K061616
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/17/2016

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 Model Number: N/A
• Device Catalogue Number: 723585
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2016
• Initial Report FDA Received Date: 12/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1