MAUDE Adverse Event Report: ABAXIS, INC. PICCOLO COMPREHENSIVE METABOLIC PANEL; COMPREHENSIVE METABOLIC PANEL (CMP)

Model Number	N/A
Medical Device Problem Code	Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2020, abaxis received a call from customer lab that they had received reagent discs that appear to have already been used.Lab reported that some of the reagent beads were already colored and had black specs.Abaxis technical support requested for customer to send the 3 rotor discs in question, back to abaxis for evaluation.Abaxis received the 3 discs and one appears to have been used with whole blood sample run.No patient or user safety issues have been reported.Additional investigation regarding this issue is underway.
Event or Problem Description
Customer says they received reagent discs that appear already used.
Additional Manufacturer Narrative
According to the additional information for this call, the customer sent the three discs in for evaluation.One disc was noted to appear used and the other two appeared unused.No black specks as reported were noticed.Abaxis technical support went over the findings with the customer and the two discs that appeared used were discarded.The customer stated that none of the discs were used.No further incidences regarding this issue have recurred since.The call was closed and no further actions were required.

• Brand Name: PICCOLO COMPREHENSIVE METABOLIC PANEL
• Common Device Name: COMPREHENSIVE METABOLIC PANEL (CMP)
• Manufacturer (Section D): ABAXIS, INC.; 3240 whipple road; union city, ca
• MDR Report Key: 9862762
• Report Number: 2939693-2020-00010
• Device Sequence Number: 19524069
• Product Code: JJG
• UDI-Device Identifier: EABA40000281
• UDI-Public: +EABA40000281/$$79453AB1/14D20201106K
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K934592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2020

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: 11/06/2020
• Device Model Number: N/A
• Device Catalogue Number: 400-0028
• Device Lot Number: 9453AB1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 03/17/2020
• Initial Report FDA Received Date: 03/20/2020
• Supplement Report FDA Received Date: 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1