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

Catalog Number 310002

Device Problems Thermal Decomposition of Device (1071); Overheating of Device (1437)

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

Event Date 01/21/2014

Event Type  malfunction  

Event Description

On (b)(6) 2013, abbott point of care (apoc) distributor repair center was contacted by a customer who reported that analyzer sn (b)(4) would not activate.The analyzer was returned for repair and during failure analysis a burnt capacitor (c26) was discovered.Apoc has determined that the component failure identified 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 dot non-fused battery carrier.Per product action (b)(4) , a red dot fused-battery carrier was released to mitigate the issue and was shipped to the customer.Analyzer sn (b)(4) was shipped on or about (b)(4) 2005 and has never been returned to apoc.Apoc has not been able to contact the customer for information on which battery carrier configuration was in use with analyzer sn (b)(4) at the time of this event.Based on the information available there were no patient or user related injuries associated with this complaint.

Manufacturer Narrative

(b)(4).

• 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: 3803252
• MDR Text Key: 4525706
• Report Number: 2245578-2014-00021
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K001387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2014
• 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: 02/19/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2005
• 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