MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT1 WIRELESS ANALYZER; I-STAT1 ANALYZER

Catalog Number	03P75-55
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Apoc labeling was evaluated during failure analysis completed on 10/24/2017.The failure was due to a defective tantalum capacitor.
Event or Problem Description
On (b)(6) 2017, abbott point of care (apoc) was contacted by a customer who reported that analyzer sn (b)(4) would not activate.The analyzer was replaced at no charge and returned for routine failure analysis.The analyzer was received on 10/16/2017 and on 10/24/2017 during failure analysis it was noted that capacitor c13 on main pcba was burnt.The customer returned the analyzer with green non-fused battery carrier.The customer was never issued battery carrier letter # apoc30aug2010 - september 2011.It is unknown how the customer obtained a green non-fused battery carrier since the customer has only been an i-stat user since 2016.The analyzer was shipped to the customer on (b)(6) 2016 with a red fused battery carrier.The customer searched the facility and stated that they only have red-fused battery carriers on site as of (b)(6) 2017.Apoc has determined that a component failure within the analyzer circuitry, may lead to the batteries becoming uncomfortably hot to touch in the area of the battery compartment when using a green non-fused battery carrier.However, the customer does state that 9 volt batteries were being used.Therefore the analyzer is likely to become hot to touch.Based on the information available, there were no patient or user related injuries associated with this complaint.

• Brand Name: I-STAT1 WIRELESS ANALYZER
• Common Device Name: I-STAT1 ANALYZER
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 7004139
• Report Number: 2245578-2017-00596
• Device Sequence Number: 799946
• Product Code: CGA
• UDI-Device Identifier: 00054749003402
• UDI-Public: 00054749003402
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K103195
• 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
• Report Date (Section B): 11/06/2017

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 Catalogue Number: 03P75-55
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2017
• Initial Report FDA Received Date: 11/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1