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

Model Number	750
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Test Result (2695)
Date of Event	09/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per service request (b)(4) dated (b)(6) 2018, the field service engineer (fse) determined that the wbc bath was not draining completely, on an intermittent basis, and found that pinch valves 4, 6, and 57 were sticking in their position, and not opening properly.The fse replaced the valve actuators at all three locations to resolve the issue.Fse confirmed that the repairs met the specified requirements per established procedures.Patient information was not provided for this event.Bec internal identifier: (b)(4).
Event or Problem Description
The customer reported that their coulter lh 750 hematology analyzer generated erroneous low hemoglobin (hgb) results for patients.Customer indicated that the instrument was generating erroneous erratic hgb count for their patient samples.Although it was initially reported that 9 patient had erroneous results, only one patient was confirmed for an erroneous result, and received a transfusion.Patient data was not provided by the customer for this event.Per telephone conversation with the lab manager on (b)(6) 2018, she indicated that as a standard quality control practice, they review all the results that they consider suspicious, and only a single (1) transfusion occurred, and not two (2) transfusions as originally reported.The lab manager put a call out, as soon as they became aware that an erroneous result had been released, but the transfusion had already occurred.To the best of her knowledge, the transfusion did not impact the general condition of the patient, and no additional medical or surgical intervention was required as a result of the transfusion.Per telephone conversation with the operator on 27-sept-18 and 01-oct-18, she indicated that the system triggered an alert for high mchc, further adding, that she recalls the system had been presenting intermittent erratic results for hemoglobin.The operator indicated that the patient received the transfusion, based on 7.7 count, and during a second run of the sample, the count was 8.4.To the best of her knowledge there was no deterioration of health based on this transfusion.

• 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: 7965460
• Report Number: 1061932-2018-01047
• Device Sequence Number: 13840947
• 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: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 750
• Device Catalogue Number: 6605632
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 09/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 10/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other