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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 08/08/2018
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 was contacted by a customer regarding i-stat crea+ cartridges that yielded a suspected discrepant creatinine result on a (b)(6) male patient. There was no additional patient information available at the time of this report. (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 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 09/17/2018. 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
Manufacturer (Section G)
ABBOTT POINT OF CARE CANADA LTD.
185 corkstown road
ottawa, ontario K2H 8 V4
CA K2H 8V4
Manufacturer Contact
linda maczuszenko
400 college road
princeton, NJ 08540
6136885949
MDR Report Key7850120
MDR Text Key119806484
Report Number2245578-2018-00226
Device Sequence Number1
Product Code CGL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K973292
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/15/2018
Device Catalogue Number03P84-25
Device Lot NumberA18139
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/17/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/19/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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