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

Catalog Number	03P84-25
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/15/2019
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 06/17/2019, abbott point of care was contacted by a customer regarding i-stat crea cartridges that yielded a suspected discrepant creatinine results on a patient.There was no patient information available at the time of this report.Nor was there product lot information.Return product is not available for investigation.(b)(6).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 limited information available that suggests the product was not performing within the variability of the assay.There is no patient information, product lot, and the er result of 0.78 is only information given and could not be confirmed.With multiple attempts to obtain information, the customer is not responding to requests.The results were reviewed and determined that the i-stat results were higher than normal but were found to be consistent with the use of hydroxyurea, a substance that is known to interfere with the i-stat creatinine assay.However, this could not be confirmed.The investigation is underway.
Additional Manufacturer Narrative
Apoc incident #: (b)(4).The investigation was completed on 07/25/2019.On (b)(6) 2019 the customer reported that the patient was on hydroxyurea.As per artwork 714183-00aa rev.Date (b)(6) 2018, creatinine/crea, hydroxyurea is a known interferent where the i-stat creatinine results will be increased.The recommendation is to use another method.It is recommended that incident 798075 be closed to a level 1 investigation using f1001 - product functioning according to specification and direction.

• Brand Name: I-STAT CREA CARTRIDGE
• Common Device Name: CREA CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 8759893
• Report Number: 2245578-2019-00164
• Device Sequence Number: 2040190
• Product Code: CGL
• UDI-Device Identifier: 10054749000125
• UDI-Public: 10054749000125
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K973292
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2019

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: 03P84-25
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/17/2019
• Supplement Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 07/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1