MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT CHEM8+ CARTRIDGE; CHEM8+ CARTRIDGE,

Catalog Number	09P31-25
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	04/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, abbott point of care (apoc) was contacted by a customer regarding i-stat chem8+ cartridge that yielded discrepant hematocrit result on a patient.There was no patient information, no results, no product information, no test/collection times and date, nor details surrounding the event at the time of this report.The customer stated that they are writing up an m&m case where a patient was over transfused after an i-stat reading of hb 54 (which was later found to be false).It is unclear and unconfirmed if the patient is related to the complaint.Information has been requested multiple times but to no avail.There has been no response.At this time there is no reason to suspect a malfunction exists.The reporting decision was based on the limited information available that suggested that product was not performing within the variability.The investigation is underway.
Additional Manufacturer Narrative
Apoc incident # (b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.
Additional Manufacturer Narrative
Apoc incident: # (b)(4).The investigation was completed on 15-jun-2023.A review of the device history records confirmed the lots passed finished goods release criteria.Retained cartridge testing of lot h22342 could not be completed due to lot expiry of 06-jun-2023.Retained cartridge testing of lots h22343 and h23012 met the acceptance criteria found in q04.01.003 rev.Ak, appendix 1 - product complaint level 2 and level 3 investigation procedure.No deficiency has been identified.
Event or Problem Description
New information was recieved from the customer on 26-apr-2023: customer poc administrator emailed that the doctor (anaesthetist who reported this issue) informed them that they are sure that the results were spuriously low due to iv fluid dilution, and that they are happy to close this submission.Poc administrator is unsure if any further information will be forth coming.Abbott point of care has determined that if the information provided by the customer - concludes that there was pre-analytical error caused by a user not following the ifu or not adhering to best practice (e.G.Drawing a blood sample from an iv line where saline is being infused without stopping the infusion for a sufficient period of time and/or not "wasting" an appropriate amount of blood before collecting the sample to be tested, then there is no reason to suspect a malfunction exists, rather use error.The unnecessary transfusion was not a result of an alleged device malfunction, but rather a clinician's choice of acting on a discrepant result without confirming it, if it was clinically unexpected.The investigation is underway.
Additional Manufacturer Narrative
Apoc incident: # (b)(4).See updates to sections: b5- new information from the customer, e1- change to initial reporter.

• Brand Name: I-STAT CHEM8+ CARTRIDGE
• Common Device Name: CHEM8+ 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 ; 185 corkstown road; princeton, NJ K2H 8-V4 ; CA K2H 8V4 ; 6136885949
• MDR Report Key: 16814894
• Report Number: 2245578-2023-00049
• Device Sequence Number: 20214510
• Product Code: JGS
• UDI-Device Identifier: 10054749001917
• UDI-Public: 10054749001917
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K053110
• 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,Followup
• Report Date (Section B): 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 09P31-25
• 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: 04/19/2023
• Supplement Date Received by Manufacturer: 04/26/2023; 06/15/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 05/04/2023; 06/20/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown