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

Catalog Number 03P75-01R

Device Problems Circuit Failure (1089); Overheating of Device (1437)

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

Event Date 12/31/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014, abbott point of care (apoc) was contacted by a customer who reported that analyzer sn (b)(4) rechargeable battery became hot to touch when placed in the downloader recharger.The customer states they did not believe that the downloader was warm or hot, but believes it is possibly contributed.This is not confirmed at this time.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 a rechargeable battery was being used.Apoc has determined that when using rechargeable batteries the product is unlikely to become hot to touch.The customer is returning analyzer sn (b)(4), rechargeable battery (bod unk), and (b)(4) for investigation.Based on the information available, there were no patient or user related injuries associated with this complaint.

Event Description

Na.

Manufacturer Narrative

(b)(4).Downloader recharger returning for investigation.Catalog#: 04p73-04.Serial# (b)(4).Manufacturer date: 05/12/2014.

Manufacturer Narrative

(b)(4).The investigation was completed on 03/31/2015.The analyzer was tested and is functioning according to specification.

• 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): FLEXTRONICS MANUFACTURING (SINGAPORE); pte ltd; 1 kallang place; singapore 3392 11; SN 339211
• Manufacturer Contact: linda maczuszenko ; 400 college road; princeton, NJ 08540 ; 6136885949
• MDR Report Key: 4401866
• MDR Text Key: 5127934
• Report Number: 2245578-2015-00002
• 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: 12/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03P75-01R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2013
• 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