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 09/27/2019

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2019, abaxis received a call from the customer lab stating that the device yielded multiple unexpected high chloride results on multiple patients.The recommended reference range for the piccolo system is 98-108mmol/l.The lab ran controls on the lot on (b)(6) 2019 and both levels were in range.A review of the batch record showed that the lot met all release criteria.The lab returned their analyzer for repair.It was observed that occasional temperature spikes above 38 degrees celsius were occurring.The heater plates were replace to resolve the reported problem.The temperature was recalibrated and the device was thoroughly cleaned.The device was sent back to the customer site where it remains.No further actions were required.This call was originally one issue that was split due to multiple panel lots (9215ab7,9272ab1, 9242ab1).This mdr addresses 9272ab1.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 multiple unexpected high chloride 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 ; 4749069
• MDR Report Key: 10347823
• MDR Text Key: 207192555
• Report Number: 2939693-2020-00083
• Device Sequence Number: 1
• Product Code: CHJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010670
• 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: 07/23/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 400-0028
• Device Lot Number: 9272AB1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Initial Date Manufacturer Received: 09/27/2019
• Initial Date FDA Received: 07/30/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/15/2015
• 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