MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-04-09 for ICHEM VELOCITY 700-7177-001 V01253 manufactured by Iris International.
[4543262]
Customer stated getting erroneous leukocyte esterase results from velocity not matching manual method.
Patient Sequence No: 1, Text Type: D, B5
[12103723]
Ichem velocity automated urine chemistry analyzer reporting several false negative on multiple analytes, specifically leukocyte esterase and bilirubin. No change in patient management was reported nor any delay of results or treatment as a result. The erroneous results generated were sent out via lis and auto-filed in patient charts (1 out of 4 erroneous results confirmed via microscopy), however, physician was notified of erroneous results prior to reviewing the results with patient. Fse inspected the unit, replaced the mis-aligned probe and calibrated. System was operational.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2023446-2014-00046 |
| MDR Report Key | 3886273 |
| Report Source | 05,06 |
| Date Received | 2014-04-09 |
| Date of Report | 2014-04-01 |
| Date of Event | 2014-04-01 |
| Date Mfgr Received | 2014-04-01 |
| Device Manufacturer Date | 2011-12-01 |
| Date Added to Maude | 2014-07-07 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SUDHA GUPTA |
| Manufacturer Street | 9172 ETON AVE. |
| Manufacturer City | CHATSWORTH CA 91311 |
| Manufacturer Country | US |
| Manufacturer Postal | 91311 |
| Manufacturer Phone | 8185277272 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICHEM VELOCITY |
| Generic Name | AUTOMATED URINE CHEMISTRY ANALYZER |
| Product Code | LJX |
| Date Received | 2014-04-09 |
| Model Number | 700-7177-001 |
| Catalog Number | V01253 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IRIS INTERNATIONAL |
| Manufacturer Address | 9172 ETON AVE. CHATSWORTH CA 91311 US 91311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-09 |