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

Catalog Number 03P75-99

Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425)

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

Event Date 09/23/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product was returned to abbott point of care on 09/24/2015.Preliminary investigation shows that the downloader/recharger (sn (b)(4)) and i-stat rechargeable power pack are performing as intended.Analyzer sn (b)(4) is currently under investigation to determine root cause.

Event Description

On 09/23/2015, abbott point of care (apoc) was contacted by a customer who reported a smoky smell from an i-stat unit.Analyzer serial number (b)(4) using a rechargeable battery was being charged in a downloader/recharger ((b)(4)) at the time of the incident.Due to both the i-stat analyzer and the downloader/recharger exhibiting a blackened appearance at the point of the ir transmission window on both devices, the facility reported that the unit appeared to have caught fire the night before at approximately 0100 am.Preliminary on site review with the customer indicated that there was a component failure within the analyzer circuitry that lead to the blackened appearance, but that there was no fire.The analyzer, downloader/recharger and rechargeable battery pack were returned for investigation.There were no patient or user related injuries associated with this complaint.

Manufacturer Narrative

(b)(4).The investigation was completed on (b)(6) 2015.The designs of the analyzer, downloader recharger, and rechargeable power pack have the necessary protection mechanisms against a short circuit condition.In the event of a short circuit condition within the analyzer, such as when component c21 fails with a low resistance, the downloader recharger and the rechargeable power pack have built in ptc resettable fuses that trip and limit the current to the analyzer, which prevent a thermal runaway condition.In the case of the hardware from the customer site, the improper installation of the ptc resettable fuse on the rechargeable power pack prevented the ptc resettable fuse from tripping and allowed the pack to supply a significant amount of current to sustain the thermal runaway of the shorted component c21.The reported customer complaint would not have occurred if the ptc resettable fuse on the rechargeable power pack functioned properly.As a result a deficiency has been identified.(b)(4) has been opened to address the deficiency.The designs of the analyzer, downloader recharger, and rechargeable power pack, which are made of flame retardant materials, also have the necessary safety feature for preventing flames from occurring, which is supported by the fact that no flames were observed during failure analysis.

• 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: 5140019
• MDR Text Key: 28253361
• Report Number: 2245578-2015-00054
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103195
• 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: Followup
• Report Date: 12/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03P75-99
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2012
• 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