MAUDE Adverse Event Report: ABAXIS PICCOLO XPRESS CHEMISTRY ANALYZER; PICCOLO ANALYZER

Catalog Number	1100-0000
Medical Device Problem Codes	Computer Software Problem (1112); Operating System Version or Upgrade Problem (2997)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6) 2023 abaxis, union city, technical support received a call from a customer site market coordinator for multiple temperature warnings on the piccolo xpress analyzer.The instrument was returned to abaxis union city, product assurance for investigation.The unit was repaired.During the investigation, a previous software version (version 3.1.39) was found on the piccolo xpress analyzer.A follow-up will be submitted pending further investigation received.
Event or Problem Description
A previous version of combined software found on the piccolo xpress chemistry analyzer.
Additional Manufacturer Narrative
07 feb 2024 quality investigation was received: the instrument was returned to abaxis union city, product assurance for investigation.Product assurance discovered that the vetscan software version 3.1.59 was present on the device instead of piccolo software version 3.1.57.The investigation identified that the incorrect software version was loaded onto the analyzer during manufacturing.This was the first occurrence of the incorrect sw being loaded on the analyzer by manufacturing.The technical support supervisor followed up with the clinic and verified that the clinic was using their own reference ranges and did not use the pre-set rangesboth the vetscan and piccolo software versions are validated and confirmed for calculation.To determine that the vetscan software did not impact the chemistry results, which is noted to be the highest risk for -mistreatment a risk assessment was performed.The source code for both versions of software was reviewed, both visual and automated using "compare it!" version 4.2.2221.The risk analysis concluded that the algorithms used by both versions of the software are identical meaning that there is no difference in how the results are calculated between the vetscan and piccolo software versions.The risk analysis concluded that the algorithms used by both versions of the software are identical meaning that there is no difference in how the results are calculated between the vetscan and piccolo sw versions.Abaxis manufacturing has checks in place for the verification of software.Operators were made aware of the one-time occurrence.A review of complaint data showed that there were no further related complaints received.No further action is required at this time.Abaxis will continue surveillance activities and monitoring of products on the market worldwide for performance and safety in our-post market surveillance program.

• Brand Name: PICCOLO XPRESS CHEMISTRY ANALYZER
• Common Device Name: PICCOLO ANALYZER
• Manufacturer (Section D): ABAXIS; 3240 whipple rd; union city CA 94587
• Manufacturer (Section G): ABAXIS; 3240 whipple rd; union city CA 94587
• Manufacturer Contact: tracy morton ; 3240 whipple rd; union city, CA 94587
• MDR Report Key: 17885667
• Report Number: 2939693-2023-00006
• Device Sequence Number: 12497344
• Product Code: JJG
• UDI-Device Identifier: EABA110000001
• UDI-Public: +EABA110000001/$$70000000P31057/16D20230222P
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K934592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 1100-0000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 02/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown