MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-17 for ICHEMVELOCITY URINE CHEMISTRY SYSTEM manufactured by Iris International, Inc..
[70214357]
Patient Sequence No: 1, Text Type: N, H10
[70214358]
Staff noticed several patients were obtaining positive urine glucose results of 50 on the velocity analyzer. Several of these patients had tests repeated on the back-up analyzer and then obtained a negative value. At this point, the instrument was taken out of service and the back-up analyzer was put into use. Service arrived two days later and we thought the issue was resolved, however the positive glucoses returned that evening and instrument was again taken out of service. Service arrived again and problem was resolved five days after the initial incident. It was determined that the sample probe wasn't being completely washed of patient samples in between aspirations and results were carrying over from previous samples. Manufacturer response: for iris velocity urine chemistry analyzer, beckman iris (per site reporter)
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6413119 |
| MDR Report Key | 6413119 |
| Date Received | 2017-03-17 |
| Date of Report | 2017-03-07 |
| Date of Event | 2017-02-08 |
| Report Date | 2017-03-07 |
| Date Reported to FDA | 2017-03-07 |
| Date Reported to Mfgr | 2017-03-07 |
| Date Added to Maude | 2017-03-17 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICHEMVELOCITY URINE CHEMISTRY SYSTEM |
| Generic Name | DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.) |
| Product Code | CDM |
| Date Received | 2017-03-17 |
| Model Number | VELOCITY |
| Device Availability | Y |
| Device Age | 6 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IRIS INTERNATIONAL, INC. |
| Manufacturer Address | 9172 ETON AVE. CHATSWORTH CA 91311 US 91311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-17 |