MAUDE Adverse Event Report: SYSMEX CORP SYSMEX CA-1500 ANALYZER; AUTOMATED BLOOD COAGULATION ANALYZER

Model Number CA-1500

Device Problems Incorrect Or Inadequate Test Results (2456); Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 04/25/2014

Event Type  Other  

Event Description

The user of two ca-1500 automated blood coagulation analyzers, serial numbers (b)(4), contacted siemens healthcare diagnostics products on (b)(6) 2014 after results that may have been erroneous were reported for fibrinogen on samples from a (b)(6) female.Thr pt, who was awaiting surgery, was given two units of cryoprecipitate, possibly unnecessarily.Two samples, id's (b)(6) were processed on (b)(6) 2014.When analyzed, both samples generated analysis time over (ato) and coagulation curve error (cce) errors on both initial and repeat testing.No numeric values were reported.Results were reported as less than 63mg/dl each time.The cryoprecipitate was given, but the pt wasn't tested again until (b)(6).An analysis fail error occurred on that sample, id 1170080a, but prothrombin time (pt) and activated partial thromboplastin time (aptt) testing was performed and results generated.Fibrinogen testing performed on (b)(6) again gave the analysis time over (ato) and coagulation curve error (cce) errors.

Manufacturer Narrative

Siemens field service was not dispatched.It is not known if results of controls were within acceptable ranges.Siemens' investigation determined that the operator reported a "less than" result for a sample that did not coagulate.Users are instructed to never report results when no numerical value is generated.No documentation of analyzer errors, alerts or malfunction was submitted.The sysmex ca-1500 system operators' manual, chapter 9 - troubleshooting explains each of the errors that can occur in section 4.5 analysis data errors.The ato means that the analysis was not completed within the normal detection time.The user is instructed to check the sample for contaminants, verify sample and reagent dispensing and then repeat the sample.If re-analysis gives results without an asterisk, the result may be reported.If an asterisk is generated, the sample may not be capable of forming a clot.The user is to follow the laboratory's alternate protocol.The cce message indicates coagulation curve abnormalities: slope drops in areas; slope is too steep in areas; coagulation time was extended for fbg due to air bubbles caused by cold buffer.The user must: "equilibrate buffer to room temperature, then re-analyze." the ca series measurement eval and check methods scientific bulletin, details combinations of codes that do occur simultaneously.Code 12 indicates that both the ato and cce codes occurred.The scientific bulletin instructs users: "do not report results without numerical values." the user did report numeric results.The pt was given two units of cryoprecipitate.Administration of blood products presents a small risk of virus transmission and allergic transfusion reactions.

• Brand Name: SYSMEX CA-1500 ANALYZER
• Type of Device: AUTOMATED BLOOD COAGULATION ANALYZER
• Manufacturer (Section D): SYSMEX CORP; kakogawa ; JA
• Manufacturer (Section G): SYSMEX CORP; 1-5-1 wakinohama-kaigandori; chuo-ku, kobe 651- 0073; JA 651-0073
• Manufacturer Contact: peter shearstone, vp regulatory ; 577 aptakisic rd; lincolnshire, IL 60069 ; 2245439514
• MDR Report Key: 3866167
• MDR Text Key: 15323632
• Report Number: 3009711478-2014-00013
• Device Sequence Number: 1
• Product Code: GKP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993299
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CA-1500
• Device Catalogue Number: 99324114
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2012
• 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: 70 YR