MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-21 for SYSMEX XE-5000 06375917 manufactured by Sysmex Corporation.
[188807602]
Several previous samples were reported to have plt clumps present based on smear reviews. The sample analysis from (b)(6) 2020 was not confirmed with additional review. It is unknown if plt clumping was present. The xe-5000 software guide (sg), chapter 6 - appendix, section 6. 1 - ip messages, discusses the manufacturer-recommended setting for the thrombocytopenia flag, which is a plt of <60 x 10^3/ul. The sample analysis from (b)(6) 2020 generated a plt result <60 x 10^3/ul. It is unknown if the user had the thrombocytopenia flag enabled at the time of the event. It is recommended to verify accurate results prior to reporting. The sysmex xe-5000 instructions for use (ifu) chapter 11 - technical information, informs users of possible sample interferences. For platelets, it warns: "where the following are present, the platelet count may be reported falsely low: platelet aggregation, pseudothrombocytopenia (induced by exposure to edta anticoagulant), giant platelets. Pseudothrombocytopenia can be caused by exposure edta anti-coagulant because of abnormal proteins present". No systemic analyzer deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10
[188807623]
An operator analyzed a patient sample on (b)(6) 2020 and a low platelet (plt) result was generated. The result was reported to the medical team and the patient was administered a plt transfusion. Between (b)(6) 2020, the patient had new samples collected which generated low plt results. On (b)(6) 2020, a new sample was collected and analyzed. A plt result within the normal range was generated. The operator performed a smear review and plt clumps were observed. Due to the presence of plt clumps on this sample, the operator suspected the sample analyzed on (b)(6) 2020 to have an erroneous low plt result. There was no harm to the patient reported due to the plt transfusion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000515253-2020-00006 |
| MDR Report Key | 9738950 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-01-24 |
| Date Mfgr Received | 2020-02-11 |
| Device Manufacturer Date | 2011-08-29 |
| Date Added to Maude | 2020-02-21 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. NANCY GOULD |
| Manufacturer Street | 577 APTAKISIC RD |
| Manufacturer City | LINCOLNSHIRE, IL |
| Manufacturer Country | US |
| Manufacturer Phone | 5439678 |
| Manufacturer G1 | SYSMEX CORPORATION |
| Manufacturer Street | 314-2 KITANO NOGUCHI-CHO |
| Manufacturer City | KAKOGAWA, HYOGO 675-0011 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 675-0011 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYSMEX XE-5000 |
| Generic Name | AUTOMATED HEMATOLOGY ANALYZER |
| Product Code | GKZ |
| Date Received | 2020-02-21 |
| Model Number | XE-5000 |
| Catalog Number | 06375917 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYSMEX CORPORATION |
| Manufacturer Address | 314-2 KITANO NOGUCHI-CHO KAKOGAWA, HYOGO 675-0011 JA 675-0011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-21 |