MAUDE Adverse Event Report: SYSMEX CORPORATION SYSMEX CA-1500 ANALYZER; COAGULATION ANALYZER

Model Number CA-1500

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

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

Event Type  Injury  

Event Description

The user of a ca-1500 automated blood coagulation analyzer, serial number (b)(4), contacted siemens healthcare diagnostics products on (b)(4) 2015 after an erroneous prothrombin time (pt) result of 145 seconds was generated by the analyzer and reported on a single patient sample.The physician did not question the results and vitamin k was administered.No error messages or other flags were generated on the patient's sample.It is unknown if the sample was repeated before reporting.A second sample was collected from the patient four hours later and a pt of 27.4 seconds was obtained.The original sample was repeated without inversion and re-centrifugation and produced a value of 33.6 seconds.No demographic or diagnostic information is known regarding the patient.It is not known if the patient was on anti-coagulant therapy.No analyzer printouts, error logs, patient reports or other corroborative documentation was supplied.Siemens submitted requests for additional information, but no responses were received.The user reported that quality control recovered within established ranges.

Manufacturer Narrative

A siemens field service engineer (fse) was dispatched.No documentation of analyzer errors, alerts or malfunction was submitted.No evidence of malfunction was detected; the siemens fse did not repair or replace any parts.A siemens quality engineer stated that preanalytical variables could not be ruled out as contributing.A sample can be compromised by improper collection techniques, such as improper mixing, as well as improper sample handling such as inadequate centrifugation in which platelet-poor plasma is not achieved.If this issue were to recur, death, serious injury, or a serious deterioration in the state of health is a remote possibility.While the analyzer is a screening device, physicians rely upon accurate data in consideration of clinical judgements, along with physical examination and other test results.The patient was administered vitamin k (route unknown), typically used in the event of warfarin anti-coagulant overdose, but the specific reason for doing so in this case was not provided.It is possible that this therapy was unnecessarily administered based upon these erroneous results.The entire clinical picture is not known.It is possible that the patient had a bleeding episode; unexpected bruising or other evidence of bleeding which might warrant such treatment.Vitamin k itself is not likely to cause harm, as it occurs naturally in leafy green vegetables.The consequence of the vitamin k administration is not known in this instance.If the patient was in a hyper-coagulable state with significant thrombosis and reversal of warfarin therapy contributed to significant thrombotic events, then the intervention may have been significant.From the information available, it appears that this was not the case.Laboratories are required to verify test results prior to reporting and to have a system in place for confirming and reporting abnormal values and/or likelihood of a death or serious injury should a similar event occur.Sysmex will report this event because vitamin k may have been unnecessary.

• Brand Name: SYSMEX CA-1500 ANALYZER
• Type of Device: COAGULATION ANALYZER
• Manufacturer (Section D): SYSMEX CORPORATION; kakogawa ; JA
• Manufacturer (Section G): SYSMEX CORPORATION; 314-2 kitano, noguchichi; kakogawa 67-0 011; JA 67-0011
• Manufacturer Contact: peter shearstone, vp ; 577 aptakisic rd; lincolnshire, IL 60069 ; 2245439514
• MDR Report Key: 4608510
• MDR Text Key: 5695416
• Report Number: 3009711478-2015-00003
• 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,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2015
• 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: 97348321
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other