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U.S. Department of Health and Human Services

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

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ABBOTT POINT OF CARE I-STAT CREA CARTRIDGE Back to Search Results
Catalog Number 03P84-25
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Information (3190)
Event Date 02/20/2018
Event Type  malfunction  
Manufacturer Narrative
(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). 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 Description
Na.
 
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.
 
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Brand NameI-STAT CREA CARTRIDGE
Type of DeviceCREA CARTRIDGE
Manufacturer (Section D)
ABBOTT POINT OF CARE
400 college road
princeton NJ 08540 6607
MDR Report Key7463826
MDR Text Key106743273
Report Number2245578-2018-00134
Device Sequence Number1
Product Code CGL
Combination Product (y/n)N
PMA/PMN Number
K973292
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received04/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/23/2018
Device Catalogue Number03P84-25
Device Lot NumberA17328
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/26/2018
Is This a Reprocessed and Reused Single-Use Device? No

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