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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT PT/INR CARTRIDGE

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ABBOTT POINT OF CARE I-STAT PT/INR CARTRIDGE Back to Search Results
Catalog Number 03P89-24
Device Problem False Positive Result
Event Date 06/26/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Cartridge lot# is unknown at this time. Apoc labeling will be evaluated during the investigation as pertaining to the event.

 
Event Description

On (b)(6) 2017, abbott point of care was contacted by a customer regarding i-stat pt/inr cartridges that yielded suspected discrepant results on a (b)(6) male patient. There was no additional patient information at the time of this report. Return product is not available for investigation. (b)(6). There are no injuries associated with this event. The investigation is underway.

 
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Brand NameI-STAT PT/INR CARTRIDGE
Type of DevicePT/INR 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 Key6836765
Report Number2245578-2017-00284
Device Sequence Number1
Product CodeGJS
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 11/10/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/31/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number03P89-24
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/03/2017
Was Device Evaluated By Manufacturer? Yes
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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