MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2017-07-07 for UF-1000I 05366719 manufactured by Sysmex Corporation.
[79351929]
The uf-1000i is an automated urine analyzer for in vitro diagnostic use for urinalysis in clinical laboratories to screen specimens containing certain unexpected or abnormal microscopic elements. All findings must be correlated with other clinical signs and symptoms prior to diagnosis and treatment. Decontamination with a broad-spectrum disinfectant and the replacement of the tubing was performed on the analyzer. This is an mdr-reportable event due to administration of unnecessary antibiotics to a patient based on a false positive result for bacteria.
Patient Sequence No: 1, Text Type: N, H10
[79351930]
From (b)(6), 2010, a hospital-based outbreak of extremely drug-resistant (xdr) pseudomonas aeruginosa was confirmed and an infection control alert was issued. It was discovered that a biofilm was formed in the fluid system of the analyzer and multiple specimens were contaminated. One patient received the antibiotic colistin due to the false positive bacteria. There was no report of patient harm due to the administration of antibiotics.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000515253-2017-00030 |
| MDR Report Key | 6694778 |
| Report Source | FOREIGN |
| Date Received | 2017-07-07 |
| Date of Report | 2018-01-23 |
| Date of Event | 2017-06-08 |
| Date Mfgr Received | 2017-06-08 |
| Date Added to Maude | 2017-07-07 |
| 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 | MR. PETER SHEARSTONE |
| Manufacturer Street | 314-2 KITANO, NOGUCHI-CHO |
| Manufacturer City | KAKOGAWA, IL 675-0011 |
| Manufacturer Country | JA |
| Manufacturer Postal | 675-0011 |
| Manufacturer Phone | 2245439514 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UF-1000I |
| Generic Name | AUTOMATED URINALYSIS ANALYZER |
| Product Code | LKM |
| Date Received | 2017-07-07 |
| Model Number | UF-1000I |
| Catalog Number | 05366719 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYSMEX CORPORATION |
| Manufacturer Address | 314-2 KITANO, NOGUCHI-CHO KAKOGAWA, 675-0011 JA 675-0011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-07-07 |