MAUDE Adverse Event Report: SYSMEX RA CO., LTD. MAIN PLANT SYSMEX CA-660; AUTOMATED BLOOD COAGULATION ANALYZER

Model Number	CA-660
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no indication of a reagent problem and no mechanical errors occurred during testing.A specific sample issue such as improper collection or handling could not be ruled out.No analyzer printouts or error logs were provided for evaluation.The pt and ptx generated "no coagulation" results.The "err[32] no coagulation" message will display asterisks "***.*" instead of data for the results.The ca-660 series instructions for use (ifu), chapter 6-display & processing of analysis results states that the asterisks indicated that the analyzer could not obtain analysis data due to an error or other cause.Chapter 12-troubleshooting, section 12.3 analysis data errors explains errors that can be generated.Error 32 indicates that coagulation was not detected.The user is advised, in the corrective action section, to make an overall evaluation of whether an error was made in the sample (such as storage or collection conditions).The operator was alerted by the analyzer to possible sample abnormality with the "no coagulation" error.The ca series measurement evaluation and check methods scientific bulletin further address the "no coagulation error 32." a graph of the scattered light plotted against time shows the changes in scattered light as the clot develops.The scattered light intensity must exceed a threshold level; otherwise the "no coagulation" error will be generated.The action steps provided are: check the sample for possible anti-coagulant contamination, hemolysis, lipemia, etc.Verify the delivery of sample reagent.Reanalyze the sample.If error 32 persists, on reanalysis, use an alternate method to confirm the data.The notation: "do not report results without numerical values" is posted on this page.
Event or Problem Description
An operator in the united states analyzed a sample, collected from an outpatient, for a prothrombin time (pt).A "no coagulation" result was generated.The sample was repeated for an extended pt (ptx), with a result of "no coagulation".The operator reported the result of "no coagulation" to the clinician.The clinician questioned the result, however the patient had already been treated with vitamin k.The same day, a new sample from the same patient was collected and analyzed on the same analyzer and the results generated were normal.The lab tech re-centrifuged and re-analyzed the original sample.This time, normal results were generated.The user confirmed with the clinician that there was no harm to the patient due to receipt of vitamin k.

• Brand Name: SYSMEX CA-660
• Common Device Name: AUTOMATED BLOOD COAGULATION ANALYZER
• Manufacturer (Section D): SYSMEX RA CO., LTD. MAIN PLANT; 1850-3 hirooka-nomura; shiojiri, nagano 399-0 702; JA 399-0702
• MDR Report Key: 7834447
• Report Number: 1000515253-2018-00012
• Device Sequence Number: 1720040
• Product Code: GKP
• UDI-Device Identifier: 04987562425716
• UDI-Public: 0104987562425716
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K031377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/30/2018

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
• Operator of Device: Health Professional
• Device Model Number: CA-660
• Device Catalogue Number: CK978289
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 08/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other