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

Model Number	400-0028
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2019, abaxis was contacted by a customer (clinic) that customer observed low potassium (k+) results using the abaxis comprehensive metabolic panel lot # 9333ab7.Results obtained were 3.2, 3.5, 3.5 mmol/l (reference range: 3.6-5.1 mmol/l).Lab did not t re-run/confirm samples with an abaxis piccolo or by another reference method.No patient information is available at this time.There are no injuries associated with this event.Investigation regarding this issue is underway.
Event or Problem Description
Low potassium (k+) patient results.
Additional Manufacturer Narrative
The customer sent the device in for repair and was received on 21-nov-2019.During evaluation of the device, the reported problem of low potassium (k+) could not be duplicated.Extracted data showed no anomalies.The system temperature was confirmed to be lower than normal range.The lamp and optics assemblies passed testing.The rotor chamber showed moderate blood splatter; but the optics tube was noted to be clean with no blood or serum residue.The repaired unit was subsequently scrapped for reasons unrelated to the nature of this complaint as part of repair service.The customer remains with the loaner device that was initially sent out and was confirmed to be working well.No further actions were required.

• Brand Name: PICCOLO COMPREHENSIVE METABOLIC PANEL
• Common Device Name: COMPREHENSIVE METABOLIC PANEL
• Manufacturer (Section D): ABAXIS, INC.; 3240 whipple road; union city CA 94587
• MDR Report Key: 9469240
• Report Number: 2939693-2019-00003
• Device Sequence Number: 16602855
• Product Code: CEM
• UDI-Device Identifier: EABA40000281
• UDI-Public: +EABA40000281/$$79333AB7/14D20200814S
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K992140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2020

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: 08/14/2020
• Device Model Number: 400-0028
• Device Catalogue Number: 400-0028
• Device Lot Number: 9333AB7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Initial Date Received by Manufacturer: 11/15/2019
• Supplement Date Received by Manufacturer: 05/14/2020
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 08/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1