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

Catalog Number	400-028
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
18 apr 2024: abaxis union city technical support received a call from a laboratory health professional reporting low potassium (k+) using the comprehensive metabolic panel (cmp) on the piccolo xpress analyzer.The patient was treated.The following results were provided: (b)(6) 2024 (unknown time): whole blood was drawn from the patient and analyzed using the comprehensive metabolic panel (cmp) lot # 4054be2 on the piccolo xpress analyzer serial number (b)(6).Results: potassium (k+) =2.8mmol/l (reference range 3.6-5.1mmol/l) the patient, a 35-year-old female was treated and left the clinic.It is unknown if the patient was currently taking any medications.The patient's clinical diagnosis history is unknown.It is unknown what treatment the physician -administered to the patient.The physician questioned the result and requested a second run to be completed on plasma to be run on 17 apr 24.17 apr 2024 (22hrs from initial draw): the whole blood sample from 16 apr 2024 was spun down.Plasma was analyzed using the comprehensive metabolic panel (cmp) lot # 4054be2 on the piccolo xpress analyzer serial number p28064.Results: (k=) =3.5mmol/l (reference range 3.6-5.1 mmol/l) the physician stopped the initial treatment and ordered 40 meq of potassium chloride (kcl) to be administered.The patient returned for treatment and was sent home.18apr2024 (unknown time): a re-draw from the patient was requested and whole blood was analyzed using the comprehensive metabolic panel (cmp) lot # 4054be2 on the - piccolo xpress analyzer serial number (b)(6).Results: (k+) =3.6mmol/l (reference range 3.6-5.1mmol/l) a return merchandise authorization (rma) was initiated for further investigation on the remainder of unused comprehensive metabolic panel lot 4054be2.A replacement lot was sent to the customer.A follow-up report will be submitted once the investigation is complete.There has been no reported patient impact contributing to patient injury or hospitalization.
Event or Problem Description
18 apr 2024: abaxis union city technical support received a call from a laboratory health professional reporting low potassium (k+) using the comprehensive metabolic panel (cmp) on the piccolo xpress analyzer.The patient was treated.
Additional Manufacturer Narrative
(b)(6) 2024 (unknown time): whole blood was drawn from the patient and analyzed using the comprehensive metabolic panel (cmp) lot # 4054be2 on the piccolo xpress analyzer serial number (b)(6).Results: potassium (k+) =2.8mmol/l (reference range 3.6-5.1mmol/l).The patient, a 35-year-old female was treated with 40 meq of potassium chloride (kcl) before returning home.It is unknown if the patient was currently taking any medications.The patient's clinical diagnosis history is unknown.The physician questioned the result and ordered the patient to stop treatment.A second run was requested to be completed on plasma to be run on (b)(6) 2024.(b)(6) 2024 (22hrs from initial draw): the whole blood sample from (b)(6) 2024 was spun down.Plasma was analyzed using the comprehensive metabolic panel (cmp) lot # 4054be2 on the piccolo xpress analyzer serial number (b)(6).Results: (k=) =3.5mmol/l (reference range 3.6-5.1 mmol/l).The patient was sent home.
Additional Manufacturer Narrative
02 may 2024: a follow-up was received on the patient.The patient is confirmed to be doing well.There is no reported patient impact contributing to patient injury or hospitalization.06jun2024 quality investigation was received: product assurance (pa) tested the customers returned unused rotors.The reported problem could not be confirmed.A total of (b)(4) unused rotors were received from the customer.Product assurance ran bi-level control samples on two different instruments and recovered in-range potassium (k+) results for all 14 of the rotors.A review of the batch record showed that there were no unacceptable low potassium readings during manufacturing and the lot met all release criteria with no deviations.A review of the complaint data showed that there were three (3) rotors from this lot, only from this clinic, reported for ow potassium out of (b)(4) rotors shipped for a complaint rate of (b)(4).There has been no observed trend for low potassium over the last 12 months ending april 2024.This complaint cannot be substantiated.

• Brand Name: PICCOLO COMPREHENSIVE METABOLIC 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 ; 2693599380
• MDR Report Key: 19216258
• Report Number: 2939693-2024-00001
• Device Sequence Number: 15193783
• Product Code: CEM
• UDI-Device Identifier: EABA40000281
• UDI-Public: +EABA40000281/$$74054BE2/14D20250201Q
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K992140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2025
• Device Catalogue Number: 400-028
• Device Lot Number: 4054BE2
• 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: 04/18/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 06/06/2024; 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female