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	02/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.
Event or Problem 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).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: 15-jul-16: 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.
Event or Problem Description
Na.
Additional 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.

• 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: 7463826
• Report Number: 2245578-2018-00134
• Device Sequence Number: 16542296
• Product Code: CGL
• UDI-Device Identifier: 10054749000125
• UDI-Public: 10054749000125
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 05/02/2018

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: 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
• Initial Date Received by Manufacturer: 04/06/2018
• Supplement Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 04/26/2018
• Supplement Report FDA Received Date: 05/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1