MAUDE Adverse Event Report: SYSMEX CORPORATION SYSMEX CA-660 COAGULATION ANALYZER

Model Number CA-660

Device Problems Unable to Obtain Readings (1516); High Test Results (2457); Device Displays Incorrect Message (2591)

Patient Problem Misdiagnosis (2159)

Event Date 10/16/2015

Event Type  Other  

Event Description

A sample from a patient in (b)(6) was analyzed for prothrombin time (pt) on (b)(6) 2015.The result data field appears as "***.*" with no numeric results generated.The international normalized ratio (inr) field appears as "*--.--." the analyzer printout demonstrates an analysis error: "err 32 no coagulation." a prolonged result was reported, the specific value was not provided.It is unknown if the patient was under warfarin anti-coagulant therapy.The patient was given vitamin k (route and dose unknown).Testing at another location yielded a near-normal result.The operator was alerted to the abnormality in the sample by the error message and the lack of numeric results generated.Om chapter 12 - troubleshooting makes the following notation to the user: when an error occurs in a sample, the analysis data relative to the error is displayed "***.*." repeat analysis is required in the case of an analysis error (shown as "***.*" in the stored data and on print out).Section 12.3 analysis data error provides errors that can occur in the various methods.The err 32, no coagulation informs the operator that the coagulation reaction cannot be detected and that a comprehensive judgement must be made, in consideration of sample integrity, including collection and handling, as well as the condition of any reagents on board.Users also are provided with the "ca series measurement evaluation and check methods" scientific bulletin that can be used to address analysis data errors.Check 5, error 32: no coagulation, states that this message occurs when the analyzer was unable to detect a coagulation reaction or a weak clot was detected.Action steps for "no coagulation" are: check the sample for possible anticoagulant contamination, hemolysis, lipemia, etc.Verify delivery of sample and reagent.Reanalyze the sample.If error 32 persists, the sample under-runs the detection limits of the detector.Use an alternate method to confirm the data.The following note in bold, capital letters is present: *do not report results without numerical values.A prolonged numeric result was reported; the patient received vitamin k as a result.

• Brand Name: SYSMEX CA-660 COAGULATION ANALYZER
• Type of Device: COAGULATION ANALYZER
• Manufacturer (Section D): SYSMEX CORPORATION; kakogawa ; JA
• MDR Report Key: 5327389
• MDR Text Key: 34474004
• Report Number: MW5058736
• Device Sequence Number: 1
• Product Code: GKZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CA-660
• Device Catalogue Number: CK978289
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR