MAUDE Adverse Event Report: ABAXIS, INC. PICCOLO METLYTE 8 PANEL

Model Number	400-0023
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Abaxis was contacted by a customer that the customer lab received high k+ patient results compared to an outside lab when running whole blood patient sample using piccolo metlyte 8 panel lot# 7461db8.Partial treatment was administered to patient based on the piccolo results.The patient was also admitted to the hospital for high ck.The hospital ran the same sample on their vitro's 5600 and received normal potassium result.Falsely high k+ result is due to the highly elevated ck value.The interference of high ck values on potassium results on the piccolo xpress system is described in the product package insert instructing customers to confirm potassium recoveries using a different methodology in such cases.Abaxis technical services explained to the customer the falsely elevated k+ result was due to the high ck and referred customer to the metlyte 8 package insert.There was no patient impact from the partial treatment and no observed trend.
Event or Problem Description
High potassium (k+) patient result.

• Brand Name: PICCOLO METLYTE 8 PANEL
• Common Device Name: PICCOLO METLYTE 8
• Manufacturer (Section D): ABAXIS, INC.; 3240 whipple road; union city CA 94587
• MDR Report Key: 9072470
• Report Number: 2939693-2019-00001
• Device Sequence Number: 1748612
• Product Code: CEM
• UDI-Device Identifier: EABA40000231
• UDI-Public: +EABA40000231/$$77461DB8/14D20181106T
• Combination Product (Y/N): N
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/12/2019

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: 11/06/2018
• Device Model Number: 400-0023
• Device Catalogue Number: 400-0023
• Device Lot Number: 7461DB8
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 09/16/2019
• 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