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	Cancer (3262)
Date of Event	09/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Apoc incident # (b)(4).Apoc labeling was evaluated during the investigation as pertaining to the event.The investigation was completed on 10/24/2018.A review of the device history record confirmed the lot passed finished goods release criteria.Retained cartridge testing met the acceptance criteria found in q04.01.003 rev.Ac, appendix 1- product complaint level 2 and level 3 investigation procedure.No deficiency has been identified.
Event or Problem Description
On (b)(6) 2018, abbott point of care was contacted by a customer regarding i-stat crea+ cartridges that yielded a suspected discrepant creatinine result on an (b)(6) year old male cancer patient.There was no additional patient information available at the time of this report.Return product is not available for investigation.(b)(6).Test and sample collection times were not provided.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.Based on the i-stat results it is suspected that the patient was taking hydroxyurea although the customer reported that hydroxyurea was not listed on medication list.The ordering doctor stated that the patient was on hydroxyurea back in (b)(6) 2018 but not now.

• 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: 8001409
• Report Number: 2245578-2018-00262
• Device Sequence Number: 11060484
• Product Code: CGL
• UDI-Device Identifier: 10054749000125
• UDI-Public: 10054749000125
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Report Date (Section B): 10/24/2018

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: 12/31/2018
• Device Catalogue Number: 03P84-25
• Device Lot Number: A18185
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR