MAUDE Adverse Event Report: SYSMEX CORP SYSMEX XS-1000I ANALYZER; AUTOMATED CELL COUNTER

Model Number XS-1000I

Device Problems Use of Device Problem (1670); Incorrect Or Inadequate Test Results (2456); Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/15/2015

Event Type  malfunction  

Event Description

The patient involved had 3 specimens drawn in ethylenediaminetetraacetic acid (edta) anti-coagulant: at a clinic on (b)(6) 2015 by finger stick in microtainer; pre-transfusion on (b)(6) by venipuncture for compatibility testing; post-transfusion on (b)(6) 2015 by venipuncture.Sample id (b)(6), was run on the xs-1000i in the manual mode at 11:46 for a cbd + diff.The sample was judged "positive," with an interpretive program (ip) message of platelet (plt) clumps? the sample generated a hemoglobin (hgb) value of 5.5 g/dl, a repeat at 11:49 gave a 5.6 result.The wbc, rbc and plt also were low.Wbc, plt and differential values were accompanied by an asterisk, "*", next to each result.Sid (b)(6) was tested in the hospital lab on another manufacturer's analyzer with similar results (data not provided).Two units of packed rbc were ordered.The venipuncture drawn for compatibility testing was not tested for a cbc prior to transfusion.One unit of packed cells was administered.The post-transfusion hgb was 12.2 g/dl, a significant jump and more than would be expected.Testing was repeated 3 days later on aged samples.

Manufacturer Narrative

A field service representative (fsr) examined the analyzer for proper function and to collect data.The xs-1000i instrument warned the user of sample abnormality requiring verification prior to reporting including the "positive" judgment and the "plt clumps?" ip message.The sample was collected by capillary means.Sample integrity was questionable with possible coagulation as reflected by the plt clump flag.The sample was analyzed in the manual mode.This mode requires the operator to mix the sample thoroughly prior to analysis: the sample may have been inadequately mixed.The anemia flag, a user-defined setting use to alert to the operator to abnormality, either was not set or did not trigger.Qc data showed the instrument was performing within specifications and historical data did not reveal an analyzer issue.While the user ultimately is responsible for proper collection and handling of patient samples and results and repeat collection and testing when indicated, this issue will be reported on the basis that incorrect results led to a patient receiving an unnecessary transfusion, carrying with the risk involved with receiving blood products: transfusion reaction, development of antibodies, exposure to blood-bone pathogens and infections.

• Brand Name: SYSMEX XS-1000I ANALYZER
• Type of Device: AUTOMATED CELL COUNTER
• Manufacturer (Section D): SYSMEX CORP; kakogawa ; JA
• Manufacturer (Section G): SYSMEX CORP; 314-2 kitano; noguchicho, kakogawa 67-0 011; JA 67-0011
• Manufacturer Contact: peter shearstone, vp ; 577 aptakisic rd; lincolnshire, IL 60069
• MDR Report Key: 4534990
• MDR Text Key: 5538132
• Report Number: 3009711478-2015-00001
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060656
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/22/2015

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
• Device Operator: Health Professional
• Device Model Number: XS-1000I
• Device Catalogue Number: 053-4231-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2015
• Initial Date FDA Received: 02/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2006
• 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 Age: 96 YR