MAUDE Adverse Event Report: ABAXIS PICCOLO GENERAL CHEMISTRY 13 PANEL; PICCOLO ROTOR

Catalog Number	400-1029
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
13 may 2024: abaxis griesheim, technical support received an email from a distributor with the following report: the customer reported opening secondary packaging labelled general chemistry 13 panel lot 4065ab8.The customer loaded the panel for use in the piccolo xpress analyzer.The piccolo xpress analyzer provides a printout of the results once the panel has been processed.The customer stated the printout read comprehensive metabolic lot 4065ac1.It was confirmed the patient was not impacted and the reported issue did not contribute to serious injury or medical intervention.An rma has been initiated.The remaining unused panels are expected to be returned for further investigation and the manufacturer has issued a capa pr id #2828430.A follow-up will be provided once the investigation is completed.
Event or Problem Description
13 may 2024: abaxis griesheim, technical support received an email from a distributor with the following report: the customer reported opening secondary packaging for the general chemistry 13 panel lot 4065ab8.The customer loaded the panel for use in the piccolo xpress analyzer.The piccolo xpress analyzer provides a printout of the results once the panel has been processed.The customer stated the printout read comprehensive metabolic lot 4065ac1.It was confirmed the patient was not impacted and the reported issue did not contribute to serious injury or medical intervention.
Additional Manufacturer Narrative
The root cause is related to human factors and was contributed to methods/ procedures.It was determined that the general chemistry 13 panel (gc13) lot 4065ab8 and comprehensive metabolic panel (cmp)lot 4065ac1 were both manufactured on 09 feb 2024 on adjoining lines.The cmp rotor lot 4065ac1 was assembled and correctly barcoded, indicating that this is a rotor lot that crossed over lines prior to packaging.Batch records were reviewed, and no defects were reported during the manufacturing or packaging process.Output logs were reviewed with no discrepancies.It is likely that after maintenance, an operator inadvertently brought cmp rotors back to the line packaging gc13 rotors and placed them on the packaging conveyor, causing a cmp rotor to be packaged within a gc13 pouch.There have been no further related complaints regarding cmp or gc13 rotors; this was determined to be an isolated issue.There have been no other complaints on any piccolo rotor marketed within the last three years ending in may 2024.No further action is required at this time.Zoetis/abaxis will continue vigilance activities and monitoring of products on the markets worldwide for performance and safety in our post-market surveillance program.

• Brand Name: PICCOLO GENERAL CHEMISTRY 13 PANEL
• Common Device Name: PICCOLO ROTOR
• 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: 19510349
• Report Number: 2939693-2024-00002
• Device Sequence Number: 19724326
• Product Code: JJG
• UDI-Device Identifier: EABA40000291
• UDI-Public: +EABA40000291/$$74065AB8/14D20250809
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K34592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2024

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 Expiration Date: 08/09/2025
• Device Catalogue Number: 400-1029
• Device Lot Number: 4065AB8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown