MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number TN,DXH 800 HEMATOLOGY SYSTEM WITH FLOOR STAND FOR SEISMIC

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Misdiagnosis (2159)

Event Date 10/08/2020

Event Type  Injury  

Manufacturer Narrative

Patient information for the following sections was not provided by the customer: patient weight, ethnicity.Qc passed on the instrument before and after the reported event indicating the instrument was working as intended.The raw data and wbc histogram was analyzed and there was no indication of hardware system failure.The sample was flagged for variant lymph (suspect messages).When the algorithm sets suspect flags, it is recommended results be reviewed appropriately to the patient population and laboratory practices (dxh800 ifu 6-42)¿.This event resulted from a use error by the operator of the instrument.The results from both instruments had prompted the operator to confirm the results with a manual smear and the operator released the results to the physician without manual smear confirmation resulting in the patient having additional antibiotics prescribed.In the communication with the bec medical director, the laboratory supervisor confirmed that the patient death was not related to the reported event and that the call initially was intended to provide feedback.The patient was a severely ill neonate.Per instrument ifu pn b16421: suspect messages suspect messages are generated by internal algorithms to convey that a clinical condition may exist with a specimen based on an abnormal cell distribution or population.Beckman coulter recommends the review of results displaying a suspect message appropriate to your patient population and laboratory practice.Bec internal identifier - case-(b)(4).Related event - case-(b)(4).

Event Description

The customer reported that on (b)(6) 2020, their two unicel dxh 800 coulter cellular analysis system generated high nrbc and wbc counts which were reported out of the laboratory.The event was isolated to one neonate patient.The patient was in the nicu (neonatal intensive care unit) and had been prescribed antibiotics previous to the event.The physician added broad-spectrum antibiotics (vancomycin and meropenem) based on the results provided.The patient died on (b)(6) 2020 at the age of four days as a result of her medical condition.And not as a result of the additional antibiotics prescribed, as confirmed by the customer laboratory.The customer provided the patient data/results for the four days the patient was tested.The data provided shows that on (b)(6) 2020, the customer ran a sample in the dxh1 (s/n (b)(4)) at 5:11 am, then, four (4) hours later, run a second sample in the dxh2 (s/n (b)(4)).The sample recoveries for both instruments were comparable.The wbc numerical results, 67.8 and 76.0, had ch flags in both cases.The nrbc absolute count (213 and 210) and its percentage calculation (315 and 277) were flagged.H (high) and r (review).Both instruments generated the suspect message ¿variant ly¿ and the system message ¿nrbc/ly overlap¿.Both instruments results prompted the operator to perform manual differential count due to their flagged critical numerical recoveries.The critical results were released to the physician by the lab without manual smear being performed as recommended by the results generated by the instrument.The previous results were released upon confirmation with manual smear.A manual smear performed after the results were reported out of the lab estimated the wbc count in 13.2.A corrected report was then sent to the physician.The customer submitted for review two (2) images of the manual smear examination.The images show large, activated, fragile lymphocytes; monocytes; nucleated rbc; reticulocytes, and rbc with macrocytosis, anisocytosis, poikilocytosis (ovalocytes, target cells, tear cells).On (b)(6) 2020, the customer technical support specialist (cts) acquired the instrument raw data for assessment.On (b)(6) 2020, the bec medical director contacted the customer medical affairs to understand lab standard operating procedure.

• Brand Name: UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
• 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: harry long ; 1000 lake hazeltine drive; m/s r590c; chaska, MN 55318 ; 9523681224
• MDR Report Key: 10802616
• MDR Text Key: 216329373
• Report Number: 1061932-2020-00168
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590683801
• UDI-Public: (01)15099590683801(11)170414
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140911
• 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: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TN,DXH 800 HEMATOLOGY SYSTEM WITH FLOOR STAND FOR SEISMIC
• Device Catalogue Number: BB66445
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 4 DA