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 2019-03-28 for CS-2500 BV981798 manufactured by Sysmex Corporation, I Square.
[140278591]
The sysmex cs-2500 evaluation and check algorithm document states "early reaction error" messages occur when an early reaction causes abnormally short aptt results. When this situation occurs, no numerical results will be generated. Instead, asterisks will display along with the error message. The user is to verify sample and reagent integrity, and repeat analysis. Once the error clears, the result can be reported. The user failed to repeat analysis and clear the error prior to result reporting. The samples generated "early reaction error" errors and a "wave changed 800nm" error. Chapter 8 - troubleshooting, section 8. 5. 2 - analysis data errors, displays the various producible errors and the meanings associated with the errors. "early reaction error" errors are generated when an abnormal reaction is detected at the initial stage of the aptt coagulation reaction. The user is to check the coagulation curve and follow the judgment criteria established by the laboratory. "wave changed 800nm" errors are generated when the wavelength changed to reduce the impact of interference. The user is to review the coagulation curve for abnormalities and repeat analysis, if indicated. It is unknown if the user was following laboratory standard operating procedure (sop) by reporting the 50% coagulation time value. Reporting the 50% coagulation time value is not recommended by the manufacturer for these error messages. Sysmex corporation (b)(4) (s-corp) performed the investigation. The investigation determined the analyzer performed as designed by alerting the user to sample abnormality.
Patient Sequence No: 1, Text Type: N, H10
[140278592]
A sample was analyzed for an activated partial thromboplastin time (aptt). The analyzer generated "early reaction error: slow reaction" and "early reaction error: early %" errors. The result was displayed as asterisks [*]. The user reported an aptt result based on the 50% coagulation time value generated by the analyzer. The physician administered heparin due to the result. The dosage is unknown. An additional sample was collected and sent to a reference lab for testing. The reference laboratory generated an aptt result of >400 seconds (sec). Three subsequent samples from the same patient were analyzed for an aptt on the same day. All samples generated "early reaction error: early %", "early reaction error: slow reaction", and/or "wave changed 800nm" errors. All aptt results were displayed as asterisks. The user reported aptt results for all samples based on the 50% coagulation time value generated by the analyzer. Erroneous aptt results were reported. The correct aptt values are unknown. It is unknown if corrected reports were issued. The patient received unnecessary heparin administration due to the result reported for the first sample. No harm was reported due to heparin administration.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000515253-2019-00008 |
| MDR Report Key | 8461647 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-03-28 |
| Date of Report | 2019-03-28 |
| Date of Event | 2019-01-19 |
| Date Mfgr Received | 2019-02-27 |
| Device Manufacturer Date | 2017-03-15 |
| Date Added to Maude | 2019-03-28 |
| 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 CORPORATION, I SQUARE |
| Manufacturer Street | 262-11 MIZUASHI NOGUCHI-CHO |
| Manufacturer City | KAKOGAWA-CITY, HYOGO 675-0019 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 675-0019 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CS-2500 |
| Generic Name | AUTOMATED BLOOD COAGULATION ANALYZER |
| Product Code | JPA |
| Date Received | 2019-03-28 |
| Model Number | CS-2500 |
| Catalog Number | BV981798 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYSMEX CORPORATION, I SQUARE |
| Manufacturer Address | 262-11 MIZUASHI NOGUCHI-CHO KAKOGAWA-CITY, HYOGO 675-0019 JA 675-0019 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-28 |