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 2019-01-10 for SYSMEX CS-2500 BV981798 manufactured by Sysmex Corporation, I Square.
[132780607]
The user reported that the initial result had a "low defective sampling" error, which alerted the operator to verify the sample result. The sysmex cs-2500 instructions for use ( ifu) does not contain documentation of this specific error message. Siemens contacted the user for confirmation and objective evidence of the specific error code, however the user did not provide any additional information. The sysmex cs-2500 ifu, chapter 2, principles of operation, section 2. 8. 9. 5 - replenishing rinse water, instructs the user: "use purified water for the rinse water. " the user installed the incorrect reagent for sample processing. Within the sysmex cs-2500 ifu, chapter 1 - introduction, it is stated: " data generated by cs-2500 is not intended to replace professional judgment in the determination of a diagnosis or in monitoring patient therapy. Operate the instrument as instructed. Reliability of test results cannot be guaranteed if there are any deviations from the instructions in this manual. If the instrument fails to function properly as a result of either the user's operation not specified in this manual or the user's utilization of a program not specified by sysmex, the product warranty would not apply".
Patient Sequence No: 1, Text Type: N, H10
[132780608]
The user reported saline was erroneously connected to the analyzer instead of rinse water. The user reported that quality control (qc) results were in range when saline was in use and that patient results were reported for prothrombin time (pt) / international normalized ratio (inr). The laboratory installed and primed the rinse water the following day and repeated the affected samples. One discordant pt/inr result for a patient on anticoagulant therapy was found. The initial sample had been reported with falsely elevated pt/inr results. Upon further review of the original result, the laboratory found there had been an indication of a "low defective sampling error". The patient's anticoagulant dosage had been changed based on the incorrect result. Anticoagulant therapy dosage prior to the event and in response to the event was not provided. The repeat analysis of the sample produced pt/inr results that were consistent with the patient's prior history. The patient returned for pt/inr testing four days after the initial collection. Test results obtained on this sample were decreased, compared to the repeat testing of the initial sample. There was no report of patient harm due to the change in anticoagulant therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000515253-2019-00001 |
| MDR Report Key | 8236999 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-01-10 |
| Date of Report | 2019-01-10 |
| Date of Event | 2018-11-09 |
| Date Mfgr Received | 2018-12-11 |
| Device Manufacturer Date | 2016-11-17 |
| Date Added to Maude | 2019-01-10 |
| 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 | SYSMEX CS-2500 |
| Generic Name | AUTOMATED BLOOD COAGULATION ANALYZER |
| Product Code | JPA |
| Date Received | 2019-01-10 |
| 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 | 2019-01-10 |