MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT ACT KAOLIN CARTRIDGE

Catalog Number	03P87-25
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Angina (1710); Chest Pain (1776); Myocardial Infarction (1969)
Date of Event	09/12/2020
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 act kaolin cartridges that yielded unexpected results on a (b)(6)- year old female patient presenting with cp, unstable angina, found to have nstemi.There was no additional patient information available at the time of this report.Return product is not available for investigation.Method: result: date: tested: i-stat: 147; (b)(6) 2020; 10:31.I-stat: 197; (b)(6) 2020; 10:57.I-stat: 142; (b)(6) 2020; 11:04.I-stat: 527; (b)(6) 2020; 11:11.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.However, the customer states that the patient was given heparin in the ed prior to the cath procedure.The patient was administered angiomax during the procedure.The customer was advised that using angiomax is outside the intended use for i-stat actk.Per i-stat system manual, art: 715878-00q; 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.It is suspected that the cause for discrepant results could be related to the use of angiomax but this cannot be confirmed.The investigation is underway.
Additional Manufacturer Narrative
Apoc incident: (b)(4).The investigation was completed on (b)(6) 2020.A review of the device history record (dhr) confirmed that the cartridge lot passed release specifications.Retained cartridge testing of act kaolin cartridge lot met the acceptance criteria outlined in appendix 1 of q04.01.003 rev.Af (product complaint level 2 and level 3 investigation procedure).No deficiency has been identified.

• Brand Name: I-STAT ACT KAOLIN CARTRIDGE
• Common Device Name: ACT KAOLIN CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 10635229
• Report Number: 2245578-2020-00105
• Device Sequence Number: 16753895
• Product Code: JBP
• UDI-Device Identifier: 10054749000156
• UDI-Public: 10054749000156
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 11/24/2020

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: 09/16/2020
• Device Catalogue Number: 03P87-25
• Device Lot Number: R20080
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 10/06/2020
• Supplement Report FDA Received Date: 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR