MAUDE Adverse Event Report: ABAXIS, INC PICCOLO COMPREHENSIVE METABOLIC PANEL; PICCOLO ROTOR

Model Number	400-0028
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is a report from a laboratory health professional from a clinic involving the comprehensive metabolic panel (part number 400-028) lot 2066ab0, ran on the piccolo xpress chemistry analyzer received by abaxis technical support.The laboratory health professional reported unexpected high sodium (na+) test results.(b)(6) 2022: abaxis technical support received a call from a health professional reporting high sodium (na+) results using the comprehensive metabolic panel (cmp) (part number 400-028) lot 2066ab0 ran on (b)(6) 2022.The clinic reran the patient samples on the metylye 8, lot# 1522ab8, the same day.The following results were provided: (b)(6) 2022 (unknown time)-whole blood was analyzed with the piccolo express analyzer using cmp lot # 2066ab0 na+ = 148 (135-145) mmol/l.(b)(6) 2022 (unknown time)- a second run using the same whole blood sample was run on the piccolo express analyzer using metlyte 8 panel lot# 1522ab8, na+=144 (135-145) mmol/l.(b)(6) 2022: the clinic called abaxis technical support to reiterate their concern with lot cmp (b)(4), lot 2066ab0 and performed a comparison of lot 2066ab0 against another cmp lot.Whole blood was analyzed with the piccolo express chemistry analyzer on three separate patients, this data was not used for diagnosis or treatment.Per information provided by the clinic, the patient was not experiencing any clinical signs or symptoms.The patient was diagnosed with hypernatremia and treated based on the piccolo express chemistry analyzer results.It could not be confirmed whether the patient was treated after the cmp results or metlyte 8 panel results ran on the (b)(6) 2022.Treatment consisted of gatorade and water prior to the patient being released.As reported, the this piccolo express chemistry analyzer -results from cmp panel lot #2066ab0 did not impact the patient or contribute to further injury or illness.The reporter was concerned about the results obtained from cmp (b)(4), lot # 2066ab0.A return merchandise authorization (rma) was initiated for further investigation on the unused panels from lot # 2066ab0 and a replacement lot was sent to the clinic.A follow-up report will be submitted once the investigation is complete.
Event or Problem Description
The customer a healthcare professional reported unexpected high sodium (na+).The patient was treated.
Additional Manufacturer Narrative
8aug2022: manufacturing site investigation response (cir 22_0064h): zoetis product assurance tested the returned rotors and could not confirm high sodium on lot# 2066ab0.Technical service support followed up with the clinic to report the investigation findings.The clinic indicated that they were no longer experiencing any further issues with the sodium results.A review of the batch record for lot # 2066ab0 confirmed there were no unacceptable readings for sodium and the lot met all release criteria with no deviations during manufacturing.A review of the complaint data showed there were 4 complaints for this rotor from the same lot reported for alleged high sodium results.(b)(4).There have been no reported patient impact contributing to patient injury or hospitalization.No further action is required at this time.

• Brand Name: PICCOLO COMPREHENSIVE METABOLIC PANEL
• Common Device Name: PICCOLO ROTOR
• Manufacturer (Section D): ABAXIS, INC; 3240 whipple rd; union city 94587
• Manufacturer (Section G): ABAXIS INC. ( SUBSIDIARY OF ZOETIS); 3240 whipple rd; union city 94587
• Manufacturer Contact: tracy morton ; 3240 whipple rd; union city, CA 94587 ; 5105122408
• MDR Report Key: 14686943
• Report Number: 2939693-2022-00003
• Device Sequence Number: 17357469
• Product Code: JGS
• UDI-Device Identifier: EABA40000281
• UDI-Public: +EABA40000281/$$72066AB0/$0000/14D20230205E+
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K993211
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2022

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: 05/02/2023
• Device Model Number: 400-0028
• Device Catalogue Number: 4000-028
• Device Lot Number: 2066AB0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2022
• Supplement Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 06/14/2022
• Supplement Report FDA Received Date: 08/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2022
• 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