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..
[175233585]
On (b)(6) 2019, abaxis received a call from a customer concerning their loaner piccolo xpress analyzer (serial number: (b)(4)) reporting incorrect reference range values on patient samples ran on (b)(6) 2019. The loaner analyzer had the newest version of software 3. 1. 35/2. 1. 55. During a preliminary investigation of the issue, abaxis confirmed a total receipt of 5 customer complaints (date of calls range from (b)(6) 2019); from four customer sites regarding the same/similar issue. Further investigation into the complaint reports, abaxis confirmed a software failure in the newly released piccolo xpress software version 3. 1. 35/2. 1. 55 which may cause the product to display incorrect reference ranges for certain analytes when gender selection is not set on the device. The issue is limited to the newly released software version 3. 1. 35/2. 1. 55 which has only been installed on loaners and repaired units and not on any new builds. Abaxis has stopped loading new software on loaners/repaired units since receiving calls regarding the issue. On (b)(6) 2019, abaxis initiated a filed action to notify all customers who have received impacted loaner/repaired analyzers with the newest software version 3. 1. 35/2. 1. 55 (fda correction/removal number: 2939693-12/16/2019-001-r). No impact to patients has been reported by customers from the issue. Additional investigation regarding the issue is underway. Since 5 individual calls for 5 instrument serial numbers have been received for this issue, 5 individual mdr submissions for each instrument serial number will be submitted (mdr 2939693-2020-00001, mdr 2939693-2020-00003, mdr 2939693-2020-00004, mdr 2939693-2020-00005).
Patient Sequence No: 1, Text Type: N, H10
[175233586]
Incorrect reference ranges for some analytes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939693-2020-00002 |
| MDR Report Key | 9541916 |
| 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 | 2018-09-12 |
| 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 |