MAUDE Adverse Event Report: ABAXIS, INC. PICCOLO BASIC METABOLIC PANEL

Catalog Number 400-0024

Device Problem High Readings (2459)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2018

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2018, abaxis received a call from the customer lab stating that the device yielded unexpected high potassium results compared to a outside lab with the same draw.The patient was admitted prior to blood sample for pain, swelling, dehydration, and rhabdomyolysys, which is an indicator for high creatine kinase.The patient was being treated with an iv.Abaxis technical support informed the lab that the package insert states the k+ assay in the piccolo system is a coupled pyruvate kinase (pk) / lactate dehydrogenase (ldh) assay.Therefore, in cases of extreme muscle trauma or highly elevated levels of creatine kinase (ck), the piccolo may recover a falsely elevated potassium (k+) value.In such cases, unexpected high potassium recoveries need to be confirmed utilizing a different methodology.The lab understood and has not experienced any more unexpected high potassium results since.The call was closed and no further actions were required.This mdr is being submitted as a result of a three (3) year retrospective review of closed complaints abaxis performed as part of its commitment to correct the fda-483 observations received on august 22, 2019.

Event Description

The customer lab reported that the device yielded unexpected high potassium results compared to an outside lab with the same draw.

• Brand Name: PICCOLO BASIC METABOLIC PANEL
• Type of Device: BASIC METABOLIC PANEL
• Manufacturer (Section D): ABAXIS, INC.; 3240 whipple road; union city, ca
• Manufacturer (Section G): ABAXIS, INC.; 3240 whipple road; union city, ca
• Manufacturer Contact: jojo bui ; 3240 whipple rd; union city, ca ; 6756500
• MDR Report Key: 10347633
• MDR Text Key: 205700395
• Report Number: 2939693-2020-00090
• Device Sequence Number: 1
• Product Code: CEM
• UDI-Device Identifier: EABA1100000001
• UDI-Public: +EABA1100000001
• 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: Other
• Type of Report: Initial
• Report Date: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 400-0024
• Device Lot Number: 8042AC2
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 26 YR