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

Model Number 750

Device Problem Output Problem (3005)

Patient Problem Test Result (2695)

Event Date 09/06/2018

Event Type  Injury  

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 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
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th avenue; miami FL 33196 2031
• Manufacturer Contact: laurie o'riordan ; 11800 sw 147th avenue; miami, FL 33196-2031 ; 3053802874
• MDR Report Key: 7965460
• MDR Text Key: 123723293
• Report Number: 1061932-2018-01047
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590264772
• UDI-Public: (01)15099590264772(11)NO-DATA
• 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: 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 750
• Device Catalogue Number: 6605632
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/06/2018
• Date Manufacturer Received: 09/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2010
• 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
• Patient Outcome(s): Other