MAUDE Adverse Event Report: ABAXIS, INC. PICCOLO XPRESS CHEMISTRY ANALYZER; PICCOLO ANALYZER

Model Number	1100-0000
Medical Device Problem Code	Device Emits Odor (1425)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2019, abaxis received a call from the customer lab reporting an issue with analyzer sn: (b)(4) stating that the device was emitting a smoke smell.No fire or injury was reported.The customer was instructed to leave the device unplugged.The customer sent the device in for repair.During evaluation of the device, it was noted that the optics showed several high coefficient of variance runs.The lamp test passed.A white rub mark was observed on the top of the heater plate.The customer's reported problem could not be duplicated and there was no trouble found with the device.The spindle motor and ball lock pin were replaced as a precaution.The device passed testing, was calibrated, cleaned, and sent back to the customer site where it remains.No further actions were taken.This mdr is being submitted as a result of a three (3) year retrospective review of closed complaints abaxis performed as part of its commitment to correct the fda-(b)(4) observations received on august 22, 2019.There has been no reoccurrence regarding the issue of burning smell with this device post repairs.
Event or Problem Description
The customer lab reported a smoke smell coming from the device.
Additional Manufacturer Narrative
As part of a three-year retrospective review of complaints for the quality improvement process, calls were identified in which the customer experienced burning odor and/or smoke.There were no injuries related to the customer complaints received, based on the potential of burning smell/smoke to lead to a potential injury.Based on mdr regulations, abaxis reported these events due to: the likelihood of this malfunction to lead to an adverse event, although there was no evidence or reports of associated adverse events.Minimal detailed documentation related to the likelihood and cause of burning odor and smoke.As part of an investigation regarding the overall reported malfunction of a burning odor and/or smoking, risk assessment, and maude database search, zoetis has concluded that the burning odor/smoke overheating complaints are a low injury risk for the user or patient.The identified malfunctions have not caused or contributed to a death or serious injury nor does the data suggest that the device or a similar device marketed would be likely to cause or contribute to a death or serious injury if the malfunction were to reoccur.Zoetis will continue to monitor complaints for burning odor/smoking/overheating to determine if any new information is obtained and any change to the risks for patients or users of the piccolo xpress analyzer.If new information is obtained, new causes where risk has not been evaluated, potential of serious injury reported or identified, the site will follow the required process for mdr reporting and timeliness.

• Brand Name: PICCOLO XPRESS CHEMISTRY ANALYZER
• Common Device Name: PICCOLO ANALYZER
• Manufacturer (Section D): ABAXIS, INC.; 3240 whipple road; ca
• MDR Report Key: 10176924
• Report Number: 2939693-2020-00066
• Device Sequence Number: 3361070
• Product Code: JJG
• UDI-Device Identifier: EABA110000001
• UDI-Public: +EABA110000001
• Combination Product (Y/N): N
• 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: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2021

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 Model Number: 1100-0000
• Device Catalogue Number: 1100-0000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2019
• Initial Date Received by Manufacturer: 01/21/2019
• Supplement Date Received by Manufacturer: 01/21/2019
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 07/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1