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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 False Positive Result (1227)
Patient Problem Breast Mass (2439)
Event Date 03/13/2017
Event Type  malfunction  
Manufacturer Narrative
Apoc incident # (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 crea cartridges that yielded a suspected discrepant result of 2.3 on a (b)(6) female 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: (b)(6) 2017, sample: a, collected: 11:40, tested: 11:53, result: 2.3; (b)(6) 2017, a, 11:40, 12:21, 0.7.There are no injuries associated with this event.The investigation is underway.
 
Manufacturer Narrative
Apoc incident # (b)(4).The investigation was completed on 04/19/2017.Retain product was tested and functioning according to specification.Return product was not available for investigation.
 
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Brand Name
I-STAT CREA CARTRIDGE
Type of Device
CREA 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 Key6412582
MDR Text Key70427793
Report Number2245578-2017-00011
Device Sequence Number1
Product Code CGL
UDI-Device Identifier10054749000125
UDI-Public(01)10054749000125(17)170528(10)A16339
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 04/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/28/2017
Device Catalogue Number03P84-25
Device Lot NumberA16339
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/13/2017
Initial Date FDA Received03/17/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/28/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/04/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age67 YR
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