MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-02 for PICCOLO XPRESS CHEMISTRY ANALYZER 1100-0000 manufactured by Abaxis, Inc..
| Report Number | 2939693-2020-00003 |
| MDR Report Key | 9541918 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-02 |
| Date of Report | 2020-01-02 |
| Date of Event | 2019-12-03 |
| Date Mfgr Received | 2019-12-04 |
| Device Manufacturer Date | 2017-05-16 |
| Date Added to Maude | 2020-01-02 |
| 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 | MS. RONI THEBO |
| Manufacturer Street | 3240 WHIPPLE RD |
| Manufacturer City | UNION CITY CA 94587 |
| Manufacturer Country | US |
| Manufacturer Postal | 94587 |
| Manufacturer Phone | 2693599544 |
| Manufacturer G1 | ABAXIS, INC. |
| Manufacturer Street | 3240 WHIPPLE ROAD |
| Manufacturer City | UNION CITY CA 94587 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94587 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2939693-12/16/2019-001-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PICCOLO XPRESS CHEMISTRY ANALYZER |
| Generic Name | PICCOLO ANALYZER |
| Product Code | JJG |
| Date Received | 2020-01-02 |
| Returned To Mfg | 2019-12-16 |
| Model Number | 1100-0000 |
| Catalog Number | 1100-0000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABAXIS, INC. |
| Manufacturer Address | 3240 WHIPPLE ROAD UNION CITY CA 94587 US 94587 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-02 |