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

Catalog Number	06F16-10
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Apoc incident # (b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.
Event or Problem Description
On (b)(6) 2019, abbott point of care (apoc) was contacted by a customer who reported that i-stat1 analyzer sn (b)(4) yielded quality check codes 29 & 23, became hot to the touch.The analyzer was not in a docking station at the time of the event.There was no additional information at the time of this report.The product was replaced at no charge and returning for investigation.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.
Additional Manufacturer Narrative
Apoc incident # (b)(4).The investigation was completed on 09/24/2019.The customer reported that analyzer s/n 321057 was hot to touch, 9v disposable batteries were used and the analyzer was not docked in the docking station at the time of the incident.The analyzer also generated quality check (qc) codes 23 and 29 when testing blood samples using cg4+ cartridges.Failure analysis did not reproduce the complaint.No deficiency has been identified.

• Brand Name: I-STAT1 ANALYZER, IMMUNO READY
• Common Device Name: I-STAT1 ANALYZER
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 8915109
• Report Number: 2245578-2019-00201
• Device Sequence Number: 1938206
• Product Code: CGA
• UDI-Device Identifier: 00054749003358
• UDI-Public: 00054749003358
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K001387
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 06F16-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Initial Date Received by Manufacturer: 08/05/2019
• Supplement Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1