MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT EC8+ CARTRIDGE

Catalog Number	600-9007-25
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.
Event or Problem Description
On (b)(6) 2022, abbott point of care was contacted by a customer regarding i-stat ec8+ cartridges that yielded a suspected discrepant sodium result of 129 mmol/l on a patient.There was no patient information available at the time of this report.Method, date, result(na); i-stat, (b)(6) 2022, 129 mmol/l; lab, (b)(6) 2022, 150 mmol/l; test/collection times not provided.Cartridge lot# information is also unknown at the time of this report.At this time there is no reason to suspect a malfunction exists.The reporting decision was based on the limited information available that suggests the product was not performing within the variability of the assay.
Additional Manufacturer Narrative
Apoc incident: # (b)(4).The investigation was completed on (b)(6) 2022.The customer reported obtaining unexpected na (sodium) patient sample results while using i-stat ec8+ cartridge lot unknown.A review of na performance verification data of i-stat versus multiple reference instruments at multiple sites for clew a42 and a43 demonstrates that the overall performance of the i-stat na is in agreement with other manufacturers.No deficiency has been determined.
Event or Problem Description
Na.

• Brand Name: I-STAT EC8+ CARTRIDGE
• Common Device Name: EC8+ 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; ottawa, ontario K2H 8 V4; CA K2H 8V4
• Manufacturer Contact: linda maczuszenko ; 400 college road; princeton, NJ 08540 ; 6136885949
• MDR Report Key: 14622929
• Report Number: 2245578-2022-00084
• Device Sequence Number: 17484584
• Product Code: CHL
• UDI-Device Identifier: 10054749000071
• UDI-Public: 10054749000071
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K940918
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2022

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
• Operator of Device: Health Professional
• Device Catalogue Number: 600-9007-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/25/2022
• Supplement Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown