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

Catalog Number 03P75-01

Device Problems Failure to Power Up (1476); Battery Problem (2885); Charging Problem (2892)

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

Event Date 06/18/2015

Event Type  malfunction  

Manufacturer Narrative

Apoc incident # (b)(4).Two analyzers were reported on the initial call.However, analyzer sn (b)(4) was filed as becoming hot to the touch per the complaint.Refer to mdr 2245578-2015-00036 for analyzer sn (b)(4) as it was suspected that only one analyzer would be returned.As a result analyzer (b)(4) was also returned and the investigation confirmed the customer's complaint in which both analyzers failed in the same manner.The investigation was completed on 09/10/2015.The failure was due to a defective tantalum capacitor.

Event Description

On 06/18/2015, abbott point of care (apoc) was contacted by a customer who reported that analyzer sn (b)(4) became warm but not hot to touch and does not hold a charge.The customer states that it has happened on multiple downloaders.Customer inserted 9v lithium batteries and the analyzer does not activate.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 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): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• Manufacturer Contact: linda maczuszenko ; 400 college road; princeton, NJ 08540 ; 6136885949
• MDR Report Key: 5095202
• MDR Text Key: 26741563
• Report Number: 2245578-2015-00050
• 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
• Report Date: 06/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03P75-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2014
• 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