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

Catalog Number 06F16-10T

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

Apoc incident (b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.

Event Description

On (b)(6) 2019, abbott point of care (apoc) was contacted by a customer who reported that i-stat1 analyzer (b)(4) became hot to touch during a software download.There was no additional information at the time of this report.The analyzer was replaced at no charge and returning for investigation.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 were being used at the time of the event.Therefore the analyzer is unlikely to become hot to touch.The product was replaced and returned for investigation.Based on the information available, there were no patient or user related injuries associated with this complaint.

Manufacturer Narrative

Apoc incident #: (b)(4).The investigation was completed on 02/20/2020.The incident was reviewed and was found to be identical in nature to an incident previously investigated.Because an identical scenario has already been investigated and this failure mode has been catalogued, no further investigation is necessary for this incident.No preventive/corrective action is required as the threshold has not been tripped and no product deficiency was found associated with the smoke emitted by the analyzer or with the inability of the analyzer to activate.Rather, this was a malfunction, which was attributed to the failure of the tantalum capacitor in the c4 location.

• Brand Name: I-STAT1 ANALYZER, IMMUNO READY, WIRELESS
• Type of Device: I-STAT1 ANALYZER
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 9450402
• MDR Text Key: 195977278
• Report Number: 2245578-2019-00294
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• PMA/PMN Number: K103195
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/25/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 06F16-10T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 12/11/2019
• Supplement Dates Manufacturer Received: 02/20/2020
• Supplement Dates FDA Received: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1