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

Catalog Number 06F16-10

Device Problems Device Emits Odor (1425); Overheating of Device (1437)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/13/2015

Event Type  malfunction  

Event Description

On (b)(6) 2015, abbott point of care (apoc) was contacted by a customer who reported that analyzer sn (b)(4) was emitting a burning smell.The customer states that the rechargeable battery, when removed was hot to the touch.Customer then inserted 9v lithium batteries and they also were hot to the touch after a short period of use.The customer states the analyzer was operating with rechargeable and batteries with a red (fused) battery 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 also a red fused battery carrier was being used.Therefore the analyzer is unlikely to become hot to touch.The product was replaced and returning for investigation.Based on the information available, there were no patient or user related injuries associated with this complaint.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The investigation was completed on 07/08/2015.The failure was due to a defective tantalum capacitor.

• 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 660
• Manufacturer (Section G): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 660
• Manufacturer Contact: linda maczuszenko ; 400 college road; princeton, NJ 08540 ; 6136885949
• MDR Report Key: 4719777
• MDR Text Key: 5580850
• Report Number: 2245578-2015-00015
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 04/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06F16-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2006
• 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