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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT POINT OF CARE CANADA LTDI-STAT CHEM 8+N CARTRIDGECHEM 8+ CARTRIDGE

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ABBOTT POINT OF CARE CANADA LTD I-STAT CHEM 8+N CARTRIDGE CHEM 8+ CARTRIDGE   Back to Search Results
Catalog Number 03P91-25
Event Date 10/11/2010
Event Type  Malfunction  
Event Description

On (b)(6) 2010, abbott point of care was contacted by a customer who reported the i-stat chem 8+ cartridge yielded a hematocrit result of 37% pcv. A separate sample, drawn at the same time as the i-stat sample, was tested on the lab instrument and the hematocrit result was 15. 4% pcv. No repeat labs performed. Patient was not treated on either hematocrit result. Patient died of respiratory failure at 6:30pm (b)(6) 2010.

 
Manufacturer Narrative

(b)(4).

 
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Brand NameI-STAT CHEM 8+N CARTRIDGE
Type of DeviceCHEM 8+ CARTRIDGE
Manufacturer (Section F)
ABBOTT POINT OF CARE CANADA LTD
ottawa, ontario
CANADA
Manufacturer (Section D)
ABBOTT POINT OF CARE CANADA LTD
ottawa, ontario
CANADA
Manufacturer (Section G)
ABBOTT POINT OF CARE CANADA LTD
185 corkstown rd
ottawa, ontario
CANADA K2H 8V4
Manufacturer Contact
peter scott
400 college rd
princeton , NJ 08540
(609) 454 -9270
Device Event Key1940485
MDR Report Key1893966
Event Key1790962
Report Number2245578-2010-00141
Device Sequence Number1
Product CodeGKF
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/03/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/03/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Service Personnel
Device EXPIRATION Date12/14/2010
Device Catalogue Number03P91-25
Device LOT NumberG10170
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received10/14/2010
Was Device Evaluated By Manufacturer? No
Date Device Manufactured06/01/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Invalid Data

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