MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-19 for PICCOLO XPRESS manufactured by Abaxis, Inc.
[23458155]
Patient Sequence No: 1, Text Type: N, H10
[23458156]
Earlier this summer, the infusion center nursing staff began to notice that potassium results that they were getting from the piccolo poct machine were unusually low. They sent blood samples to the hospital lab and discovered there was a large discrepancy in the results (>0. 5). The representative from abaxis was notified and a loaner machine was provided a week later, while the manufacturer investigated the machine. On two weeks after the original identification of this problem, the staff again began to notice low potassium results on the loaner machine and when the samples were sent to the hospital lab, there was an unacceptable discrepancy. Multiple lot numbers and controls were done and it was narrowed down to 3 lot numbers of the disc that is used in the machine. The manufacturer was notified and indicated that there was not a recall on the lot numbers identified by staff. Prior to the loaner machine, there were 6-12 incorrect results identified. Since the loaner has been in use, 13 errors in results has occurred on multiple patients. There has been no patient harm, one patient did receive 20 mcq of k+, however, there was no harm. The infusion center nursing staff continues to closely monitor every potassium result. Manufacturer response for piccolo xpress chemistry analyzer, (brand not provided) (per site reporter). The representative was contacted as well as abaxis technical support. The original machine was returned to abaxis per their request so they could investigate as initially it was thought to be an error with the machine and that perhaps the machine needed cleaning (per abaxis). However, after the loaner machine was received (7/14/2015) 13 additional errors were discovered. After multiple lot numbers and controls were tested, it was narrowed down to the discs and 3 different lot numbers. The 3 lot numbers were returned and replacements of different lot numbers were received. When asked specifically if a recall would take place, staff were told not at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5013321 |
| MDR Report Key | 5013321 |
| Date Received | 2015-08-19 |
| Date of Report | 2015-08-03 |
| Date of Event | 2015-07-14 |
| Report Date | 2015-08-03 |
| Date Reported to FDA | 2015-08-03 |
| Date Reported to Mfgr | 2015-08-03 |
| Date Added to Maude | 2015-08-19 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | PICCOLO XPRESS |
| Generic Name | ANALYZER, CHEMISTRY, CENTRIFUGAL, FOR CLINICAL USE |
| Product Code | JJG |
| Date Received | 2015-08-19 |
| Returned To Mfg | 2015-07-08 |
| Lot Number | 5225AB6, |
| ID Number | 5172BB0, 5205AB7 |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| 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 | 2015-08-19 |