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

Catalog Number	06F16-10
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.
Event or Problem Description
On (b)(6) 2018, abbott point of care (apoc) was contacted by a customer who reported visible smoke coming from i-stat1 analyzer (b)(4) after replacing the rechargeable battery.There was no additional information at the time of this report.The analyzer and rechargeable battery pack were 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.
Additional Manufacturer Narrative
Apoc incident # (b)(4).The investigation was completed on 09/13/2018.Analyzer s/n (b)(4) was returned because it emitted smoke.Failure analysis determined that the cause of the problem was the failure of a 100f tantalum capacitor (apoc p/n: 013827-01 01) c26 on the main board of the analyzer, between the primary battery and ground.The capacitor had failed such that it created a short circuit between the battery and ground; current flowing through the shorted capacitor caused heat damage, which gave the capacitor a burned appearance.The failures of the tantalum capacitors are a characteristic of the part and should be attributed to the manufacturer's reliability of this type of capacitor.According to the trending for august 2018, the number of capacitor failures in the model 300 analyzer that are allowable based on the component's reliability calculations is 282 for the past year (ending in august 2018), and the total number of the actual failures is 99, the current incident included.Therefore, no preventive/corrective action is required as the threshold has not been tripped and no product deficiency was found associated 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 c26 location.

• 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: 7738306
• Report Number: 2245578-2018-00198
• Device Sequence Number: 1618645
• Product Code: CGA
• UDI-Device Identifier: 00054749003709
• UDI-Public: 00054749003709
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/19/2018

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: 06F16-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Initial Date Received by Manufacturer: 07/25/2018
• Supplement Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 08/01/2018
• Supplement Report FDA Received Date: 09/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1