MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT1 ANALYZER, IMMUNO READY

Catalog Number	04P75-30
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Apoc incident # (b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.
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) became hot to touch.The i-stat was shipped on 01/24/2017 and was operating with rechargeable, and/or 9v lithium batteries (w/red fused carrier).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 states that rechargeable batteries and/or 9v lithium batteries (w/red fused carrier) were being used.Therefore the analyzer is unlikely to become hot to touch.The product was replaced and being returned for investigation.Based on the information available, there were no patient or user related injuries associated with this complaint.
Additional Manufacturer Narrative
(b)(4).The investigation was completed on 05/11/2017.The failure was due to a defective tantalum capacitor.

• Brand Name: I-STAT1 ANALYZER, IMMUNO READY
• Common Device Name: I-STAT1 ANALYZER
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 6356744
• Report Number: 2245578-2017-00010
• Device Sequence Number: 976729
• Product Code: CGA
• UDI-Device Identifier: 00054749003693
• UDI-Public: (01)00054749003693
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K001387
• 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): 05/20/2017

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: 04P75-30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/14/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2017
• Supplement Report FDA Received Date: 05/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1