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

Catalog Number 310002

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Date 06/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Apoc labeling was evaluated during the investigation as pertaining to the event.The analyzer was returned due to rattling noise.On (b)(6) 2018 during failure analysis a burnt c13 capacitor was discovered.

Event Description

On (b)(6) 2018, abbott point of care (apoc) was contacted by a customer who reported a rattling noise on i-stat 1 analyzer sn# (b)(4).The analyzer was returned with no reports of smoke or heat related events.On (b)(6) 2018 during failure analysis a burnt c13 capacitor was discovered.The customer did not provide battery carrier or power source at the time of the call.Upon several attempts the information was still not available.Shipping records shows that the analyzer was shipped on (b)(6) 2005 prior to the release of fused battery carriers in 2011.Shipping records show that the customer has not purchased fused-batteries, red fused battery carriers, nor rechargeable batteries.The customer was sent the product action information but did not respond to the correspondence regarding the action.At this time, it is unknown but assumed that the customer could be using green non-fused battery carriers which are obsolete and have been removed from the field.The customer is not responding to request for information.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.

• Brand Name: I-STAT1 ANALYZER, IMMUNO READY
• Type of Device: I-STAT1 ANALYZER
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• Manufacturer (Section G): FLEXTRONICS MANUFACTURING (SINGAPORE); pte ltd; 1 kallang place; singapore 33921 1; SN 339211
• Manufacturer Contact: linda maczuszenko ; 400 college road; princeton, NJ 08540 ; 6136885949
• MDR Report Key: 7727235
• MDR Text Key: 115540136
• Report Number: 2245578-2018-00191
• Device Sequence Number: 1
• Product Code: CGA
• UDI-Device Identifier: 00054749003907
• UDI-Public: 00054749003907
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K001387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 310002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1