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

Model Number 400-0023

Device Problem High Readings (2459)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/05/2018

Event Type  malfunction  

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 Description

High potassium (k+) patient result.

• Brand Name: PICCOLO METLYTE 8 PANEL
• Type of Device: PICCOLO METLYTE 8
• Manufacturer (Section D): ABAXIS, INC.; 3240 whipple road; union city CA 94587
• Manufacturer (Section G): ABAXIS, INC.; 3240 whipple road; union city CA 94587
• Manufacturer Contact: roni thebo ; 3240 whipple rd; union city, CA 94587 ; 2693599544
• MDR Report Key: 9072470
• MDR Text Key: 188320643
• Report Number: 2939693-2019-00001
• Device Sequence Number: 1
• Product Code: CEM
• UDI-Device Identifier: EABA40000231
• UDI-Public: +EABA40000231/$$77461DB8/14D20181106T
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/06/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention