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

Model Number 400-0028

Device Problem High Readings (2459)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

This is a report from a laboratory healthcare professional involving the piccolo xpress analyzer and the comprehensive metabolic panel (cmp) part# 400-0028.The laboratory health professional reported unexpected high creatinine (cre) test results with the following details: this laboratory healthcare professional called initially on (b)(6) 2022 and called back on (b)(6) 2022 to report case details.It is unknown when the samples were run in (b)(6) 2022.(b)(6) 2022 - unknown time - blood was drawn from the patient and analyzed (whole blood) using the piccolo xpress analyzer sn# (b)(4) and (cmp), rotor lot #2173ab1.Results: cre - 4.4 mg/dl (range: 0.6-1.2 mg/dl).The patient was treated for appendicitis based on the clinical signs and symptoms presented (the exact clinical signs and symptoms were not reported).(b)(6) 2022 - 1 hour later- an add-on test- was ordered.The initial sample (whole blood) was analyzed on a different analyzer - piccolo xpress analyzer sn# (b)(4) and a metlyte-8 metabolic panel part # 400-0023, rotor lot #1283ab5.Results: cre - 0.7 mg/dl (range: 0.6-1.2 mg/dl).The piccolo xpress analyzer results were not used to treat or diagnose the patient.The patient was not impacted and the analyzer results did not contribute to any further diagnosis, treatment, illness, or injury.The reporter was concerned about the results obtained from the piccolo xpress analyzer sn# (b)(4) with cmp part # 400- 0028, lot # 2173ab1.A return merchandise authorization (rma) was initiated on 5july2022 for the unused panels.The unused panels were received on 01august2022 for further investigation.A replacement was sent to the customer.The reporter has chosen not to return the analyzer for investigation.A follow-up report will be submitted once the investigation is complete.

Event Description

A laboratory healthcare professional reported unexpected high creatinine (cre) results.Per report, a patient was treated based on symptoms of appendicitis - not due to the piccolo xpress analyzer results.

Manufacturer Narrative

07nov2022: the quality assurance investigation was complete.Manufacturing investigation response: the clinic observed a high creatinine (cre) result while running whole blood on the comprehensive metabolic panel ( cmp) lot 2173ab1 compared to a rerun of the same sample on a separate rotor and analyzer approximately one hour later 4.4mg/dl versus 0.7 mg/dl respectively (reference range 0.6-1.2 mg/dl).The patient arrived at the clinic with appendicitis and was sent to the er for treatment.The patient was not treated based on the piccolo cre result.The clinic ran controls on lot 2173ab1 on 01 jul 2022 and confirmed the unit "passed qc" but did not provide the results to the technical support representative (tsr) the tsr requested that the clinic return the remaining boxes of the cmp rotor lot#2173ab1 for investigation.Product assurance (pa) tested the customers returned unused rotors and could not confirm high cre.All results at all levels were within range near the target.The initial cre result is likely an outlier due to random variation.A review of the batch record was completed and confirmed lot 2173ab1 met all manufacturing release criteria.A review of the complaint data showed that there were only 2 rotors from this lot reported for high cre out of 8,850 rotors shipped for a complaint rate of (b)(4).There was no reported patient impact and no observed trend for high cre over the last 12 months ending july 2022.This complaint cannot be substantiated.No further action is required.

• Brand Name: PICCOLO COMPREHENSIVE METABOLIC PANEL
• Type of Device: PICCOLO ROTOR
• Manufacturer (Section D): ABAXIS, INC.; 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: 15854127
• MDR Text Key: 305246661
• Report Number: 2939693-2022-00005
• Device Sequence Number: 1
• Product Code: CGX
• UDI-Device Identifier: EABA40000281
• UDI-Public: +EABA40000281/$$72173AB1/14D20230420D+
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K942782
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2023

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/04/2023
• Device Model Number: 400-0028
• Device Catalogue Number: 400-0028
• Device Lot Number: 2173AB1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2022
• Initial Date FDA Received: 11/23/2022
• Supplement Dates Manufacturer Received: 07/05/2022; 07/05/2022
• Supplement Dates FDA Received: 11/23/2022; 01/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2022
• 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
• Patient Outcome(s): Disability