MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT ALINITY INSTRUMENT

Catalog Number	02R60-01
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	04/26/2023
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 02-may-2023, abbott point of care was contacted by a customer regarding i-stat alinity analyzer sn (b)(6) that yielded a discrepant result of >1000 on a patient.There was no patient information, event details, nor additional test available at the time of the initial call.On (b)(6) 2023 the customer provided results but no patient information or details surrounding the event.The customer is returning the i-stat alinity sn (b)(6) for investigation.Method date tested results heparin heparin dose sn(b)(6) 26-april-2023 10:59 596 10:54 400ie/kg + 10000ie priming) sn(b)(6) 26-april-2023 10:59 693 10:44 400ie/kg + 10000ie priming) sn(b)(6) 26-april-2023 11:33 521 11:44 5000 ie sn(b)(6) 26-april-2023 11:33 567 11:44 5000 ie sn(b)(6) 26-april-2023 12:21 636 ni ni sn(b)(6) 26-april-2023 12:21 734 ni ni sn(b)(6) 26-april-2023 13:08 492 ni ni sn(b)(6) 26-april-2023 13:08 601 ni ni sn(b)(6) 26-april-2023 13:36 400 ni ni sn(b)(6) 26-april-2023 13:36 486 ni ni sn(b)(6) 26-april-2023 14:58 >1000 14:17 ni sn(b)(6) 26-april-2023 14:58 325 14:17 ni 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.An investigation is underway.It is also noted that actk cartridge lot# r23021 was investigated previously on incident# (b)(4) and there was no deficiency identified.
Additional Manufacturer Narrative
Apoc incident: # (b)(4).The investigation was completed on 15-aug-2023.The customer reported that i-stat alinity instrument s/n (b)(6) generated unexpected act k patient sample results.The conclusion of the investigation is that the complaint is not confirmed.Further investigation on the issue cannot be performed without return of analyzer s/n (b)(6) to apoc-princeton.A rocketware search spanning three months found no related incidents and no evidence of a trend.No deficiency has been identified.

• Brand Name: I-STAT ALINITY INSTRUMENT
• Common Device Name: ALINITY
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540
• 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: 17161974
• Report Number: 2245578-2023-00070
• Device Sequence Number: 20228266
• Product Code: JGS
• UDI-Device Identifier: 00054749002597
• UDI-Public: 00054749002597
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K153357
• 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): 08/23/2023

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: 02R60-01
• Device Lot Number: 806038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2023
• Supplement Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 06/20/2023
• Supplement Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2020
• 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: 65 YR
• Patient Sex: Male