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	01/12/2022
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) 2020, abbott point of care was contacted by a customer regarding i-stat ec8+ cartridges that yielded a suspected discrepant potassium result of >9.0 on a patient.There was no patient information available at the time of this report.Ec8+; (b)(6) 2022; @12:24 am; k+ 2.8 mmol/l.Ec8+; (b)(6) 2022; @5:19 am; k+ >9 mmol/l.Ec8+; (b)(6) 2022; @10:39 am; k+ 3.2 mmol/l.The customer stated that they suspect but cannot confirm that the result of ec8+, (b)(6) 2022 @ 5:19 am, k+ >9 mmol/l was run on a sample collected in edta tube.Customer is unable to provide any cartridges to return for investigation for ec8+ lot k21158 expired (b)(6) 2022.Customer is aware they were using expired cartridges at the time of the event.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 the limited information available that suggests the product was not performing within the variability of the assay.
Event or Problem Description
Na.
Additional Manufacturer Narrative
Apoc incident: # (b)(4).The investigation was completed on (b)(6) 2022.A review of the device history record (dhr) confirmed that cartridge lot k21158 passed finished goods (fg) release criteria.Due to expiry, retained cartridge testing could not be performed.No deficiency has been identified.

• 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: 13415722
• Report Number: 2245578-2022-00017
• Device Sequence Number: 5232536
• 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): 02/15/2022

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 Expiration Date: 01/06/2022
• Device Catalogue Number: 600-9007-25
• Device Lot Number: K21158
• 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: 01/14/2022
• Supplement Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 02/01/2022
• Supplement Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2021
• 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