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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT CA19-9XR REAGENT KIT; SYSTEM, TEST, CARBOHYDRATE AG (CA19-9), FOR MONIT AND MGMT OF PANCREATIC CANCER
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ABBOTT GMBH ARCHITECT CA19-9XR REAGENT KIT; SYSTEM, TEST, CARBOHYDRATE AG (CA19-9), FOR MONIT AND MGMT OF PANCREATIC CANCER Back to Search Results
Catalog Number 02K91-32
Device Problem High Test Results (2457)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/25/2020
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process.A follow up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.This report is being filed on an international product, list number 02k91-32 that has a similar product distributed in the us, list number 02k91-33.
 
Event Description
The customer reported a falsely elevated architect ca 19-9xr result on a (b)(6)-yr old male patient.It is unknown if the patient has pancreatic cancer.Results provided: (b)(6) 2020 = 1061.01 u/ml, (b)(6) 2020 = 21.98 u/ml.No impact to patient management was reported.
 
Manufacturer Narrative
A review of complaints for architect ca 19-9xr (lot 10031m800) assay determined that there are no trends for the product related to patient results.A review of the manufacturing documentation did not identify any issues associated with the customer¿s observation.Historical performance in the field of reagent lots using world wide data through abbottlink was evaluated.The patient median result for lot 10031m800 was analyzed and found to be within established baselines and confirms no systemic issues for this lot.Return testing was not completed as returns were not available.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect ca 19-9xr (lot 10031m800) assay.
 
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Brand Name
ARCHITECT CA19-9XR REAGENT KIT
Type of Device
SYSTEM, TEST, CARBOHYDRATE AG (CA19-9), FOR MONIT AND MGMT OF PANCREATIC CANCER
Manufacturer (Section D)
ABBOTT GMBH
max-planck-ring 2
wiesbaden 65205
GM  65205
MDR Report Key10726881
MDR Text Key212746945
Report Number3002809144-2020-01044
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 12/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/14/2020
Device Catalogue Number02K91-32
Device Lot Number10031M800
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/30/2020
Initial Date FDA Received10/23/2020
Supplement Dates Manufacturer Received12/08/2020
Supplement Dates FDA Received12/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ARC I2K PROC MOD, 03M74-01, ISR54849.; ARC I2K PROC MOD, 03M74-01, ISR54849.; ARC I2K PROC MOD, 03M74-01, ISR54849
Patient Age79 YR
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