MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-08-30 for SYSMEX CA-660 CK978289 manufactured by Sysmex Ra Co., Ltd. Main Plant.
[118826966]
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.
Patient Sequence No: 1, Text Type: N, H10
[118826967]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000515253-2018-00012 |
| MDR Report Key | 7834447 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-08-30 |
| Date of Report | 2018-08-30 |
| Date of Event | 2018-06-29 |
| Date Mfgr Received | 2018-07-31 |
| Device Manufacturer Date | 2017-06-26 |
| Date Added to Maude | 2018-08-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. JASNA FRONTZ |
| Manufacturer Street | 577 APTAKISIC RD |
| Manufacturer City | LINCOLNSHIRE IL 60069 |
| Manufacturer Country | US |
| Manufacturer Postal | 60069 |
| Manufacturer Phone | 2245439753 |
| Manufacturer G1 | SYSMEX RA CO., LTD. MAIN PLANT |
| Manufacturer Street | 1850-3 HIROOKA-NOMURA |
| Manufacturer City | SHIOJIRI, NAGANO 399-0702 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 399-0702 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYSMEX CA-660 |
| Generic Name | AUTOMATED BLOOD COAGULATION ANALYZER |
| Product Code | GKP |
| Date Received | 2018-08-30 |
| Model Number | CA-660 |
| Catalog Number | CK978289 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYSMEX RA CO., LTD. MAIN PLANT |
| Manufacturer Address | 1850-3 HIROOKA-NOMURA SHIOJIRI, NAGANO 399-0702 JA 399-0702 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-30 |