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

Catalog Number 03P75-01

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Date 08/04/2020

Event Type  malfunction  

Manufacturer Narrative

Apoc incident #: (b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.

Event Description

On 06/04/2020, abbott point of care (apoc) was contacted by a customer who reported that i-stat analyzer sn (b)(4) was too hot to touch and there was damage to the case.There was no additional information at the time of this report.The customer stated that the analyzer was docked on i-stat downloader recharger drc-79334 and they found the analyzer hot to touch while in the docking station.Apoc has replaced the analyzer, downloader recharger drc-79334, alolng with the rechargeable battery at no charge to be returned for investigation as a complete unit.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 were being used at the time of the event.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.

Manufacturer Narrative

Apoc incident #: (b)(4).The investigation was completed on 28-oct-2020.During failure analysis, it was determined that the failure of components d14 and q1 on the main board of drc s/n (b)(6) caused the drc to become warm to touch.The failure of these two components on the main board of drc s/n (b)(6) could potentially have caused analyzer s/n (b)(6) (with rechargeable power pack) to become hot to touch when docked in the drc at the customer site.Analyzer s/n (b)(6) did not become hot when docked in a known-good drc during the evaluation.The cosmetic damage to analyzer s/n (b)(6) was caused by a drop.The cause of qc code 91 was determined to be damaged component r89 on the main board of analyzer s/n (b)(6) when the analyzer was dropped.

• Brand Name: I-STAT1 ANALYZER, IMMUNO READY, WIRELESS
• Type of Device: I-STAT1 ANALYZER
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton, nj
• MDR Report Key: 10386456
• MDR Text Key: 238136666
• Report Number: 2245578-2020-00086
• Device Sequence Number: 1
• Product Code: CGA
• UDI-Device Identifier: 00054749001408
• UDI-Public: 00054749001408
• Combination Product (y/n): N
• PMA/PMN Number: K103195
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• 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: 10/19/2020
• Date Manufacturer Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1