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

Model Number	1100-0000
Medical Device Problem Codes	Labelling, Instructions for Use or Training Problem (1318); Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 12-oct-2020, abaxis received a call from a customer reporting a discrepancy in the packaging insert for the comprehensive metabolic panel (document number: (b)(4)).The customer stated that, under the section, "effects of exogenous and therapeutic substances," table 2 indicates that the concentrations listed are the highest concentrations tested.However, in table 3, the values listed for ascorbic acid, and dopamine are higher than the values indicated in table 2 and pyruvate is not listed.Additional 510(k)s also relevant for this issue are: k942782 (cgx), k934592 (cga), k950164 (cka), and k934592 (cig).Abaxis is currently conducting a root cause investigation into the potential discrepancy concerns and will provide a follow-up report following the investigation.
Event or Problem Description
The customer reported a discrepancy found with the information indicated in the packaging insert for the comprehensive metabolic panel (document number: (b)(4)).
Additional Manufacturer Narrative
Additional information received with investigation findings.The investigation was performed on all piccolo xpress package inserts to evaluate the extent of the issue.The investigation confirmed the customer complaint of discrepancies between table 2 and table 3 of the package inserts of the comprehensive metabolic panel and the basic metabolic panel.This error was also encountered in further package inserts for which abaxis/zoetis never received any customer complaint.To classify the risk for patient harm, zoetis reached out to a medical professional for assistance and guidance.A health hazard evaluation was completed and signed by a medical professional.It was deemed that the risk for a serious injury or deterioration in patient health related to above error is considered as low to very low.The following list shows the panels with effected parameters as well as the associated 510k file numbers related to those parameters.Electrolyte panel - k992140 metlyte 8 panel - k950164, k992140 basic metabolic panel - k950164, k992140 renal function panel - k950164, k992140 comprehensive metabolic panel - k950164, k992140 metlyte plus crp - k950164, k992140 metlac 12 panel - k950164, k992140 amlyte 13 - k950164, k992140 the package inserts for electrolyte panel (2001), metlyte 8 panel (2001), basic metabolic panel (2001), renal function panel (2002) comprehensive metabolic panel (2003), metlyte plus crp (2009), metlac 12 panel (2012) and amlyte 13 (2014) were investigated at "revision a".All of them already showed the issue, but renal function panel has a different design in "revision a." the review of the package inserts showed that three different designs are currently in use.Action items to correct the issue include aligning the 17 package inserts for section 9 sub-section effects of therapeutic substances.A medical professional outlined in his review that the current presentation is not easy to understand for non-laboratory professionals.Capa 20-022-a has been opened to address the issue and pi label correction.Zoetis will work with specialists to present the data in relation to therapeutic relevant ranges and outline if provided ranges are therapeutic or physiologic.

• 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: 10779159
• Report Number: 2939693-2020-00101
• Device Sequence Number: 13737849
• Product Code: CGX
• UDI-Device Identifier: EABA110000001
• UDI-Public: +EABA110000001
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2021

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: 400-0028
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/12/2020
• Supplement Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 02/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1