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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 Low Test Results (2458)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/14/2019
Event Type  malfunction  
Manufacturer Narrative
This report is being filed on an international product, architect ca 19-9xr, list 2k91-32, that has a similar product distributed in the us, list number 2k91-33.Patient information: no further information was obtained.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
 
Event Description
The customer reported a falsely depressed architect ca 19-9xr result for a (b)(6) female pancreatic cancer patient.Sample id (b)(6) generated 18.43 with repeat of 15.09 u/l.The sample was tested on architect at an alternate facility generating 34.79 u/ml.The customer indicated the result was discrepant with the (b)(6) 2019 architect result of 280 u/ml.The sample was further tested on the immulite (332.1 u/ml) and cobas (218.2 u/ml) generating similar result to the (b)(6) result.No impact to patient management was reported.
 
Manufacturer Narrative
A review of complaint activity for the architect ca 19-9xr assay did not identify any adverse trends.Review of complaint activity associated with lot 93018m800 did not identify an increase in complaint activity.Using worldwide field data, the performance of the lot 93018m800 was evaluated.The patient median result for the lot was within the established control limits indicating no unusual performance.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Labeling was reviewed and sufficiently addresses the customers issue.No systemic issue or deficiency of the architect ca 19-9xr assay was identified.
 
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Brand Name
ARCHITECT CA 19-9XR
Type of Device
CA 19-9
Manufacturer (Section D)
ABBOTT GERMANY
max-planck-ring 2
wiesbaden 65205
GM  65205
MDR Report Key8528694
MDR Text Key142482677
Report Number3002809144-2019-00209
Device Sequence Number1
Product Code NIG
Combination Product (y/n)N
PMA/PMN Number
K052000
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 05/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/13/2019
Device Catalogue Number02K91-32
Device Lot Number93018M800
Was Device Available for Evaluation? Yes
Date Manufacturer Received05/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ARCHITECT I1000SR, LIST 01L87-97; ARCHITECT I1000SR, LIST 01L87-97; SERIAL (B)(4). ; SERIAL (B)(4).
Patient Age75 YR
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