MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-01-31 for UF-5000 FULLY AUTOMATED URINE PARTICLE ANALYZER BN344411 manufactured by Sysmex Corporation, I Square.
[178016946]
The user reported the initial csf results to the clinician without verifying the results. The accuracy of the initial csf results could not be confirmed. No analyzer malfunction has been identified. The english version (used in europe) of the uf-5000 general information, chapter 1. 1, intended use, describes: fully automated urine particle analyzer uf-5000 is an in vitro diagnostic instrument for the determination of clinical parameters in human urine and human body fluids. The instrument can only be used to analyze human urine, body fluid, and control material samples. The uf-5000 basic operation, chapter 3 - analyzing samples, section 3. 3 - preparing samples, describes: samples analyzed in the instrument are as follows: human urine, human body fluid (including cerebrospinal fluid, serous fluid (peritoneal and pleural), synovial fluid, and peritoneal dialysis fluid). Analyzing csf and body fluid samples on the uf-5000 is not cleared for ivd use in the united states. The north american version of the uf-5000, general information, chapter 1. 1 intended use states: fully automated urine particle analyzer is an automated urine particle analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The sysmex uf-5000 fully automated urine particle analyzer analyzes the following parameters in urine samples: rbc, wbc, epithelial cells, cast, bacteria and flags the presence of the following: pathologic cast, crystals, sperm, yeast like cell and mucus.
Patient Sequence No: 1, Text Type: N, H10
[178016947]
An operator in denmark alleged a cerebrospinal fluid (csf) sample was analyzed and generated falsely elevated polymorphonuclear leukocytes (pmn) and falsely decreased mononuclear cells (mn). There were no error messages or flags with the results. These results were not verified with microscopic evaluation. Due to due to the patient's clinical signs and symptoms and results from the csf sample, the patient received antibiotics and anti-viral treatment beginning on (b)(6) 2020. Additional tests for blood culture and csf culture were initiated. Six days later, another csf sample was collected and analyzed, which generated lower pmn results and higher mn results as compared to the initial csf values. These results were confirmed by microscopic evaluation. Antibiotic treatment was discontinued and steroid treatment was started based on the second csf sample results. No patient harm was reported based on the administration of antibiotic treatment, delay of steroid treatment or the second csf collection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000515253-2020-00003 |
| MDR Report Key | 9655919 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-01-31 |
| Date of Report | 2020-01-31 |
| Date of Event | 2020-01-02 |
| Date Mfgr Received | 2020-01-09 |
| Device Manufacturer Date | 2016-08-18 |
| Date Added to Maude | 2020-01-31 |
| 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 60069 |
| Manufacturer Country | US |
| Manufacturer Postal | 60069 |
| Manufacturer Phone | 2245439678 |
| Manufacturer G1 | SYSMEX CORPORATION, I SQUARE |
| Manufacturer Street | 262-11 MIZUASHI NOGUCHI-CHO |
| Manufacturer City | KAKOGAWA-CITY, 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 | UF-5000 FULLY AUTOMATED URINE PARTICLE ANALYZER |
| Generic Name | URINE PARTICLE COUNTER |
| Product Code | LKM |
| Date Received | 2020-01-31 |
| Model Number | UF-5000 |
| Catalog Number | BN344411 |
| 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, 675-0019 JA 675-0019 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-31 |