MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT CG8+ CARTRIDGE

Catalog Number 03P88-25

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/16/2022

Event Type  malfunction  

Manufacturer Narrative

Apoc incident # (b)(4).Note: expiration date for cg8+, lot# w21351= 08/16/2022 (not exporting to submission report).Apoc labeling will be evaluated during the investigation as pertaining to the event.

Event Description

On 08-aug-2021, abbott point of care was contacted by a customer regarding i-stat cg8+ cartridges that yielded suspected discrepant pco2 result of 120 mmhg on a 76 day old male patient.There was limited information and no patient information.Return product is not available for investigation.Method: i-stat, date: (b)(6) 2022, tested: 06:44, pco2(mmhg) 120; abl 90, (b)(6) 2022, 06:48, 63.There are no injuries associated with this event.At this time there is no reason to suspect a malfunction exists.The reporting decision was based on limited information available that suggests the product was not performing within the variability of the assay.Product lot informtaion was not presented, but requestged.The investigation is underway.

Manufacturer Narrative

Apoc incident: (b)(4).The investigation was completed on 05-oct-2022.A review of the device history record confirmed the cartridge lot met finished goods release criteria.Due to the expiration of cg8+ cartridge lot w21351, retained cartridge testing could not be performed.Pco2 performance verification shows that the overall performance of the i-stat is in agreement with other manufacturers.No deficiency has been determined for cg8+ cartridge lot w21351.

• Brand Name: I-STAT CG8+ CARTRIDGE
• Type of Device: CG8+ CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• Manufacturer (Section G): ABBOTT POINT OF CARE CANADA LTD.; 185 corkstown road; K2H 8 V4; CA K2H 8V4
• Manufacturer Contact: linda maczuszenko ; 400 college road; princeton, NJ 08540 ; 6136885949
• MDR Report Key: 15328628
• MDR Text Key: 305370165
• Report Number: 2245578-2022-00117
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 10054749000163
• UDI-Public: 10054749000163
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K940918
• 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: 10/11/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 03P88-25
• Device Lot Number: W21351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2022
• Initial Date FDA Received: 08/31/2022
• Supplement Dates Manufacturer Received: 10/05/2022
• Supplement Dates FDA Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 76 DA
• Patient Sex: Male