MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-26 for PICCOLO XPRESS CHEMISTRY ANALYZER 1100-0000 manufactured by Abaxis, Inc..
[180858996]
On 01/28/20, abaxis received a call from customer lab getting 430b error - spindle motor stuck on their piccolo xpress analyzer serial number (b)(4). Lab also reported there was smoke coming out of the disk tray when the error occured. No fire or injury was reported. Abaxis technical support advised customer that instrument needs service and to return back to abaxis. Investigation into the returned analyzer is underway.
Patient Sequence No: 1, Text Type: N, H10
[180858997]
430 b error - spindle motor stuck.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939693-2020-00007 |
| MDR Report Key | 9753772 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-01-28 |
| Date Mfgr Received | 2020-01-28 |
| Device Manufacturer Date | 2019-04-26 |
| Date Added to Maude | 2020-02-26 |
| 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 | MS. RONI THEBO |
| Manufacturer Street | 3240 WHIPPLE RD |
| Manufacturer City | UNION CITY, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 3599544 |
| Manufacturer G1 | ABAXIS, INC. |
| Manufacturer Street | 3240 WHIPPLE ROAD |
| Manufacturer City | UNION CITY, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PICCOLO XPRESS CHEMISTRY ANALYZER |
| Generic Name | PICCOLO ANALYZER |
| Product Code | JJG |
| Date Received | 2020-02-26 |
| Model Number | 1100-0000 |
| Catalog Number | 1100-0000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-26 |