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

Catalog Number 400-0028

Device Problem High Readings (2459)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/08/2018

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2018, abaxis received a call from the customer lab stating that the device yielded an unexpected high potassium result compared to a draw on a different device and lot.The lab treated the patient to lower potassium levels then redrew a sample approximately 45 minutes later and tested the sample on a different piccolo analyzer and lot.The customer then set the test tube to the lab for analyzing.The lab ran controls on a different lot on 07-march-2018.The control samples were sent to test the lot in question.The lab ran controls on the lot on 09-march-2018 and both levels were within range.Abaxis technical support provided in-service training based on the potassium troubleshooting chart previously sent by technical support.The abaxis representative reinforced the protocol to rerun an abnormal result before treating a patient.The lab has not experienced any more unexpected high potassium results since and the device remains at the customer site.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 an unexpected high potassium result compared to a draw on a different device and lot.

• Brand Name: PICCOLO BASIC METABOLIC PANEL
• Type of Device: PICCOLO 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 ; 4749069
• MDR Report Key: 10347626
• MDR Text Key: 205701070
• Report Number: 2939693-2020-00088
• Device Sequence Number: 1
• Product Code: CEM
• 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: 400-0028
• Device Lot Number: 7431AC6
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 72 YR