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

Catalog Number 03P84-25

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Information (3190)

Event Date 02/23/2018

Event Type  malfunction  

Manufacturer Narrative

Apoc incident # (b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.

Event Description

On (b)(6) 2018, abbott point of care (apoc) was contacted by a customer regarding i-stat crea+ cartridges that yielded a suspected discrepant creatinine result on a patient.There was no patient information available at the time of this report.Return product is not available.(b)(6).Collection and test times are unknown.There are no injuries associated with this event.At this time there is no reason to suspect a malfunction exists.Apoc suspects that the high results are because the use of hydroxyurea.However this is not confirmed at this time.The customer states that they do not have visibility to that information and they have provided all the information that they are able to.Per i-stat system manual, art: 714183-00y.Rev.Date: (b)(6) 2015: hydroxyurea is a dna synthesis inhibitor used in the treatment of various forms of cancer, sickle cell anemia, and hiv infection.This drug is used to treat malignancies including melanoma, metastatic ovarian cancer, and chronic myelogenous leukemia.It is also used in the treatment of polycythemia vera, thrombocythemia, and psoriasis.At typical doses ranging from 500 mg to 2 g/day, concentrations of hydroxyurea in patients' blood may be sustained at approximately 100 to 500 [?]mol/l.Higher concentrations may be observed soon after dosing or at higher therapeutic doses.The reporting decision was based on the limited information available that suggests the product was not performing within the variability of the assay.The investigation is underway.

Manufacturer Narrative

Apoc incident # (b)(4).The investigation was completed on 04/26/2018.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 Description

Na.

• Brand Name: I-STAT CREA CARTRIDGE
• Type of Device: CREA CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 7463821
• MDR Text Key: 107194475
• Report Number: 2245578-2018-00135
• Device Sequence Number: 1
• Product Code: CGL
• UDI-Device Identifier: 10054749000125
• UDI-Public: 10054749000125
• Combination Product (y/n): N
• PMA/PMN Number: K973292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/23/2018
• Device Catalogue Number: 03P84-25
• Device Lot Number: A17328
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1