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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 Low Test Results (2458)
Patient Problem No Code Available (3191)
Event Date 10/03/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4): diagnostic imaging performed, it's unknown if iv contrast was used, or the impact to patient management. An evaluation is in process. A follow up report will be submitted when the evaluation is complete. An evaluation is in process.
 
Event Description
The customer observed a falsely depressed ca19-9 result on the architect i2000sr analyzer. The patient ((b)(6)) has not been diagnosed with pancreatic cancer and is suspected to have ovarian cancer. The following data was provided: initial 15. 46, repeat 15. 20 u/ml. A value of 270 was obtained on another method at another facility. The patient underwent an image diagnosis and it is unknown if iv contrast was used. No further details regarding the patient or procedure could be obtained.
 
Manufacturer Narrative
On (b)(6) 2016 additional information was provided by the customer. The imaging was performed due to the other hospitals results. The ca19-9 results did not cause the imaging. Based upon this new information, this complaint is no longer a reportable event.
 
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Brand NameARCHITECT CA 19-9XR
Type of DeviceCA 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 Key6061604
MDR Text Key58539544
Report Number1415939-2016-00102
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
Type of Report Initial,Followup
Report Date 11/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number02K91-28
Device Lot Number62015M800
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/07/2016
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

Patient Treatment Data
Date Received: 10/27/2016 Patient Sequence Number: 1
Treatment
ARCHITECT I2000SR ANALYZER; LN (B)(4) SN (B)(4)
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