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

Catalog Number	04P75-01
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	08/17/2023
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 06-sep-2023, abbott point of care was contacted by a customer regarding act kaolin cartridges that yielded discrepant results of >1000 three times patient.There was no patient information.Return product is not available for investigation.Method.Date.Result.I-stat, (b)(6) 2023 >1000.I-stat, (b)(6) 2023 >1000.I-stat, (b)(6) 2023 >1000.I-stat, (b)(6) 2023 389.No heparin times.No heparin dose information.No heparin reversal information.Per i-stat system manual (art: 714185-00q), the i-stat kaolin activated clotting time (kaolinact) test is an in vitro diagnostic test that uses fresh, whole blood, and is used to monitor high-dose heparin anticoagulation frequently associated with cardiovascular surgery.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.It is unknown if reversal was as administered to the patient.Information was requested but to no avail.There was limited information surrounding the procedure.An investigation is underway.
Additional Manufacturer Narrative
Apoc incident: # (b)(4).The investigation was completed on 10-nov-2023.The customer reported that analyzer s/n (b)(6) produced unexpected act kaolin patient result (>1000) three times for the same patient with act kaolin cartridges from lot r23151, which did not match with the patient clinical picture.The customer also mentioned that the same patient sample was retested on another i-stat 1 analyzer, and it produced expected results using the same act kaolin cartridge lot.Failure analysis could not be performed as analyzer s/n (b)(6)has not been returned to flex.A rocketware search spanning three months revealed no similar incidents and no evidence of a trend.No deficiency has been identified.
Event or Problem Description
New information: customer provided patient information, medication, analyzer product information.
Additional Manufacturer Narrative
Apoc incident: # (b)(4).The investigation was completed on 05-dec-2023.The customer reported that analyzer s/n (b)(6) produced unexpected act kaolin patient result (>1000) three times for the same patient with act kaolin cartridges from lot r23151, which did not match with the patient clinical picture.The customer also mentioned that the same patient sample was retested on another i-stat 1 analyzer, and it produced expected results using the same act kaolin cartridge lot.Failure analysis did not reproduce the complaint.Analyzer s/n (b)(6) functioned according to specification during testing and produced results that were within the acceptance ranges.A rocketware search spanning three months revealed no similar incidents and no evidence of a trend.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 INC.; 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 ; pte ltd; 1 kallang place; singapore, ontario, NJ 33921-1 ; SN 339211 ; 6136885949
• MDR Report Key: 17773158
• Report Number: 2245578-2023-00129
• Device Sequence Number: 2673822
• Product Code: CGA
• UDI-Device Identifier: 00054749000340
• UDI-Public: 00054749000340
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K023582
• 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): 12/12/2023
• 2 Devices were Involved in the Event: 1 2

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: 11/27/2023
• Device Catalogue Number: 04P75-01
• Device Lot Number: R23151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/06/2023
• Supplement Date Received by Manufacturer: 11/10/2023; 12/05/2023
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 11/14/2023; 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2023
• 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 Age: 74 YR
• Patient Sex: Male