MAUDE Adverse Event Report: ABAXIS, INC. PICCOLO RENAL FUNCTION PANEL; PICCOLO RENAL PANEL

Model Number	400-0027
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Abaxis was contacted by a customer (clinic) that customer observed low potassium (k+) result compared to result from outside lab (labcorp).Result from the clinic on whole blood patient sample using the abaxis renal function panel lot # 9172ac5 was 3.0 mmol/l (reference range: 3.6 - 5.1 mmol/l) and result from outside lab on serum sample from the same draw was 3.7 mmol/l (reference range: 3.5 - 5.2 mmol/l).Patient was treated based on the the piccolo result alone but treatment was stopped when the labcorp result was reported.The clinic's practice is to treat patients based on the piccolo results and adjust treatment later as needed.Abaxis recommends analysis by another method for results obtained outside the piccolo reference range.The clinic also ran controls using the renal panel lot 9172ac5 and controls were within range indicating the piccolo system was operating as expected.The complainant reported no patient impact from the temporary treatment.
Event or Problem Description
Low potassium (k+) patient result.

• Brand Name: PICCOLO RENAL FUNCTION PANEL
• Common Device Name: PICCOLO RENAL PANEL
• Manufacturer (Section D): ABAXIS, INC.; 3240 whipple road; union city CA 94587
• MDR Report Key: 9211011
• Report Number: 2939693-2019-00002
• Device Sequence Number: 10864963
• Product Code: CEM
• UDI-Device Identifier: EABA40000271
• UDI-Public: +EABA40000271/$$79172AC5/14D20200423N
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K992140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/23/2020
• Device Model Number: 400-0027
• Device Catalogue Number: 400-0027
• Device Lot Number: 9172AC5
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 10/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR