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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT CA 19-9XR
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ABBOTT LABORATORIES ARCHITECT CA 19-9XR Back to Search Results
Catalog Number 02K91-28
Device Problem High Test Results (2457)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/28/2016
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process.A follow up report will be submitted when the evaluation is complete.
 
Event Description
The customer observed a falsely elevated (b)(4) result on the architect i2000sr analyzer.The following data was provided: sid (b)(4) initial 78.33, repeat 35.58 u/ml.Unknown sid from october: initial 60 u/ml, repeat 30 u/ml.There was no impact to patient management.
 
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Brand Name
ARCHITECT CA 19-9XR
Type of Device
CA 19-9
Manufacturer (Section D)
ABBOTT LABORATORIES
100 abbott park road
abbott park IL 60064 3500
Manufacturer (Section G)
ABBOTT LABORATORIES
100 abbott park road
abbott park IL 60064 3500
Manufacturer Contact
noemi romero-kondos, rn bsn
100 abbott park road
dept. 09b9, lccp1-3
abbott park, IL 60064-3537
224667-512
MDR Report Key6184672
MDR Text Key62687141
Report Number1415939-2016-00126
Device Sequence Number1
Product Code NIG
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K052000
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Health Professional
Type of Report Initial
Report Date 12/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number02K91-28
Device Lot Number64006M800
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/27/2016
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
ARCHITECT I2000SR ANALYZER; LN 03M74-01 SN (B)(4)
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