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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 03/14/2017
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) 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) year old male patient. There was no additional patient information at the time of this report. The customer states that return product is not available for investigation. Date: method: time: inr: (b)(6) 2017, i-stat, 15:00, >8. 0. (b)(6) 2017, i-stat, 15:12, 2. 7. (b)(6) 2017, lab, 15:46, 2. 9. There are no injuries associated with this event. The investigation is underway.

 
Manufacturer Narrative

(b)(4). The investigation was completed on 06/01/2017. Retain product was tested and functioning according to specification. Return product was not available for investigation.

 
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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 Key6432102
Report Number2245578-2017-00014
Device Sequence Number1
Product CodeGJS
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 06/09/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/24/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/14/2017
Device Catalogue Number03P89-24
Device LOT NumberS16330A
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 Received06/01/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/25/2016
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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