MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-30 for PICCOLO XPRESS BLOOD CHEMISTRY ANALYZER 400-0028 manufactured by Abaxis, Inc..
[27631798]
The event description is per medwatch uf (b)(4). An investigation into the report has been initiated. Preliminary findings indicate the piccolo xpress blood chemistry analyzer system met all product release specifications. The eval is not yet complete. A supplemental report will be submitted when the device analysis is completed.
Patient Sequence No: 1, Text Type: N, H10
[27631800]
Per medwatch (b)(4); "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 (greater than 0. 5). The representative from abaxis was notified and a loaner machine was provided a week later, while the mfr 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 mfr was notified and indicated that there was not a recall in 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 pts. There has been no pt harm, one pt did receive 20 mcq of k+, however, there was no harm. The infusion center nursing staff continues to closely monitor every potassium result. 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 (07/14/2015) 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 was told not at this time.
Patient Sequence No: 1, Text Type: D, B5
[56455366]
As a supplement to the information furnished originally, abaxis has completed a root cause investigation into this report. The investigation determined that the analyzer in question met performance specifications but was operating at the low end of the normal range for potassium. A planned manufacturing calibration adjustment from 3. 70 mmol/l to 3. 55 mmol/l was made in october 2013 to center the potassium calibration rotor performance. This had the effect of reducing overall complaint rate of high potassium readings relative to a reference from (b)(4) in 2013 to less than (b)(4) in 2015. However, the adjustment also increased the incidence of low potassium readings slightly with some analyzers including the one in question. All rotor lots met release criteria both before and after the calibration adjustment. The health hazard evaluation conducted concluded there was negligible risk of adverse health consequences due to low potassium measurements. Abaxis is taking active measures to improve k+ performance and continues to monitor low potassium complaints. As of end of august 2016, the overall low potassium complaint rate has dropped by (b)(4) to (b)(4) from a peak of (b)(4) in october 2015.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2939693-2015-00001 |
| MDR Report Key | 5124639 |
| Date Received | 2015-09-30 |
| Date of Report | 2015-08-25 |
| Date of Event | 2015-07-14 |
| Date Mfgr Received | 2015-08-25 |
| Device Manufacturer Date | 2015-05-29 |
| Date Added to Maude | 2015-10-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | DAVID CALHOUN |
| Manufacturer Street | 3240 WHIPPLE RD. |
| Manufacturer City | UNION CITY CA 94587 |
| Manufacturer Country | US |
| Manufacturer Postal | 94587 |
| Manufacturer Phone | 5106756500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PICCOLO XPRESS BLOOD CHEMISTRY ANALYZER |
| Generic Name | PICCOLO, |
| Product Code | CEM |
| Date Received | 2015-09-30 |
| Returned To Mfg | 2015-07-20 |
| Model Number | 400-0028 |
| Catalog Number | 400-0028 |
| Lot Number | 5225AB6 |
| Device Expiration Date | 2016-05-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ABAXIS, INC. |
| Manufacturer Address | 3240 WHIPPLE RD. UNION CITY CA 94587 US 94587 |
| Brand Name | PICCOLO XPRESS BLOOD CHEMISTRY ANALYZER |
| Generic Name | PICCOLO, |
| Product Code | JJG |
| Date Received | 2015-09-30 |
| Returned To Mfg | 2015-07-20 |
| Model Number | 400-0028 |
| Catalog Number | 400-0028 |
| Lot Number | 5225AB6 |
| Device Expiration Date | 2016-05-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABAXIS, INC. |
| Manufacturer Address | 3240 WHIPPLE RD. UNION CITY CA 94587 US 94587 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-30 |