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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GERMANY ARCHITECT CA 19-9XR

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ABBOTT GERMANY ARCHITECT CA 19-9XR Back to Search Results
Catalog Number 02K91-32
Device Problem High Test Results (2457)
Patient Problem No Code Available (3191)
Event Date 07/26/2018
Event Type  Injury  
Manufacturer Narrative
Unnecessary invasive diagnostic tests were performed, with no further negative impact. This report is being filed on an international product, architect ca19-9 list 02k91-32 that has a similar product distributed in the us, list number 02k91-29 and 02k91-33.
 
Event Description
The customer observed a falsely elevated ca19-9 result for one patient on the architect i2000sr analyzer. The following data was provided for a patient of unknown gender and unknown age sid (b)(6): at a physical check-up 3 months ago, a result of 100 u/ml was obtained, repeated at a later date (date unknown) as 80 u/ml. Repeated (b)(6) 2018 as 201 u/ml. An echo examination, ct examination without contrast, upper and lower endoscopy were performed. No cancer was found. No adverse impact to patient management from these additional invasive diagnostic tests were reported.
 
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Brand NameARCHITECT CA 19-9XR
Type of DeviceCA 19-9
Manufacturer (Section D)
ABBOTT GERMANY
max-planck-ring 2
wiesbaden 65205
GM 65205
Manufacturer (Section G)
ABBOTT GERMANY
max-planck-ring 2
wiesbaden 65205
GM 65205
Manufacturer Contact
noemi romero-kondos, rn bsn
100 abbott park road
dept. 09b9, lccp1-3
abbott park, IL 60064-3537
224667-512
MDR Report Key7738473
MDR Text Key115658661
Report Number3002809144-2018-00102
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/13/2018
Device Catalogue Number02K91-32
Device Lot Number82033M800
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 Received08/28/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/01/2018 Patient Sequence Number: 1
Treatment
ARCHITECT I2000SR ANALYZER; LN 03M74-01, SN: (B)(4)
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