MAUDE Adverse Event Report: ABAXIS, INC. PICCOLO COMPREHENSIVE 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 09/10/2019

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2019, abaxis received a call from the customer lab stating that the device yielded unexpected high potassium results compared to outside lab results.The patient was sent to the emergency room and was redrawn.Investigation of the event showed that the lab did not run controls on either lot and stated that they did not know they needed to run controls.A review of the batch record showed that there were no issues with potassium in manufacturing and the lot met all release criteria.The lab has not experienced any high potassium results on any other patients prior to or after reporting this complaint.The device remains at the customer site and no further actions were required.This call was originally one issue that was split due to multiple panel lots (9195ab1, and 9205ab6).This mdr addresses 9195ab1.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 reported that the device yielded unexpected high potassium results compared to outside lab results.

• Brand Name: PICCOLO COMPREHENSIVE 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 ; 5793958
• MDR Report Key: 10347605
• MDR Text Key: 205161604
• Report Number: 2939693-2020-00084
• 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: 07/24/2020

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: 9195AB1
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2019
• 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: 29 YR