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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 12/14/2016
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) 2016, 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. The customer states that return product is available for investigation. Date, method, sample, type, test time, result: (b)(6) 2016, i-stat, a , capillary wb , 1408 , 5. 7; (b)(6) 2016, i-stat, b, capillary wb, 1413, 3. 0; (b)(6) 2016, i-stat, c, capillary wb, 1433, 4. 6; (b)(6) 2016, lab, d, citrated plasma , unk, 4. 9. There are no injuries associated with this event. The investigation is underway.

 
Manufacturer Narrative

Apoc incident # (b)(4). The investigation was completed on 02/28/2017. Retain product and customer returns were tested and functioning according to specification.

 
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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 Key6229816
Report Number2245578-2017-00001
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 03/03/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/06/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2017
Device Catalogue Number03P89-24
Device LOT NumberS16247
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/20/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/28/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/03/2016
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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