MAUDE Adverse Event Report: SYSMEX CORPORATION XT-4000I; DIFFERENTIAL CELL COUNTER

Model Number XT-4000I

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reaction (2414)

Event Date 12/30/2018

Event Type  Injury  

Manufacturer Narrative

The sysmex xt-4000i analyzer is used in clinical laboratories as a screening device to detect abnormalities in patient samples.The body fluid analysis mode of the xt-4000i uses the 4diff scattergram and the rbc distribution obtained from a specialized analysis sequence to calculate and display the wbc (wbc-bf) counts, mononuclear cell (mn)/polymorphonuclear cell (pmn) counts and percentages, and rbc (rbc-bf) counts found in the body fluid.The xt-4000i instructions for use (ifu), chapter 11 - technical information, section 11.1 - performance/specifications, lists the acceptable upper limit for rbc-bf background values as 0.003 × 10^6/ul.The linearity for rbc-bf is listed to be within ±3.0% or within ±0.030 × 10^6/ul for counts between 0.00 - 5000 × 10^3/ul.Establishment of the clinical reportable range (crr) is a medical judgment made by each laboratory and is based in part on the assay technology.Values outside the crr are reported as < or > a numeric value.It is good laboratory practice to verify automated body fluid cell count results with another methodology, such as a manual hemocytometer count or examination of a cytospin preparation.Obtaining results at the same level of the background count should alert the user that additional verification is needed.The user failed to verify accurate results appropriately, prior to release.

Event Description

On (b)(6) 2018, analysis of a clear, colorless cerebrospinal fluid (csf) generated an elevated red blood cell count (rbc-bf) result.The result was reported and the physician ordered a computed topography (ct) scan due to suspicion of a possible aneurysm and/or subarachnoid hemorrhage.During the ct procedure, the patient felt she was having a reaction to the contrast media that had been administered.The patient was given prednisone to treat the adverse reaction.The physician questioned the initial result of the csf analysis and requested a manual cell count.No rbcs were observed on the manual count.A corrected report was issued.There was no report of additional treatment or serious harm to the patient.

• Brand Name: XT-4000I
• Type of Device: DIFFERENTIAL CELL COUNTER
• Manufacturer (Section D): SYSMEX CORPORATION; 314-2 kitano; noguchi-cho; kakogawa, hyogo 675-0 011; JA 675-0011
• Manufacturer (Section G): SYSMEX CORPORATION; 314-2 kitano; noguchi-cho; kakogawa, hyogo 675-0 011; JA 675-0011
• Manufacturer Contact: jasna frontz ; 577 aptakisic rd; lincolnshire, IL 60069 ; 2245439753
• MDR Report Key: 8298220
• MDR Text Key: 134775468
• Report Number: 1000515253-2019-00005
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 04987562413959
• UDI-Public: 4987562413959
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/01/2019

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
• Device Operator: Health Professional
• Device Model Number: XT-4000I
• Device Catalogue Number: BY539823
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/07/2019
• Initial Date FDA Received: 02/01/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/19/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR