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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 02K91-39
Device Problem Low Test Results (2458)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/27/2018
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. There is no additional patient information provided due to privacy issues. This report is being filed on an international product list 2k91-39, that has a similar us product distributed in the us, list 2k91-33. Complete information for patient information: patient identifier
=
sid (b)(6).
 
Event Description
The customer reported falsely depressed architect ca19-9 results generated on one patient. The results provided were: historic ca19-9
=
66. 2u/l; on (b)(6) 2018, sid (b)(6)
=
11. 25 / second test error code 3350 [measurement items cannot be processed for the second time. Suction error of (sample pipettor) with sample (sh sample)]; generated / third test
=
13. 31u/l. There was no reported impact to patient management.
 
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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 Key8260610
MDR Text Key133859072
Report Number3002809144-2019-00018
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 02/04/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/09/2019
Device Catalogue Number02K91-39
Device Lot Number88046M800
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/25/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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