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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 No Information (3190)
Event Date 08/24/2017
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 crea cartridges that yielded a suspected discrepant crea result on a female patient.There was no additional patient information at the time of this report.Creturn product is available for investigation.Method : sample: collection - time: test - time: results: sample: i-stat, venous, (b)(6)2017 afternoon, (b)(6)2017 unk, 0.9, a.I-stat, venous, (b)(6)2017 10:10am, (b)(6)2017 10:20am, 4.9, b.Alera, venous, (b)(6)2017 10:50am, (b)(6)2017 11:08am, 0.6, c.There are no injuries associated with this event.The investigation is underway.
 
Manufacturer Narrative
Apoc incident # (b)(4).The investigation was completed on 10/30/2017.Retain product was tested and functioning according to specification.Return product was not available.
 
Event Description
Na.
 
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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 Key6854487
MDR Text Key85627871
Report Number2245578-2017-00294
Device Sequence Number1
Product Code CGL
UDI-Device Identifier10054749000125
UDI-Public(01)10054749000125
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 11/03/2017
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 Date11/28/2017
Device Catalogue Number03P84-25
Device Lot NumberA17160
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/24/2017
Initial Date FDA Received09/11/2017
Supplement Dates Manufacturer Received10/30/2017
Supplement Dates FDA Received11/03/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/09/2017
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 Age62 YR
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