Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 11/24/2020
Event Type  malfunction  
Manufacturer Narrative
Complete information from patient identifier sid (b)(6).All available patient information has been included.No additional patient details are available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
 
Event Description
The customer reported falsely elevated architect ca 19-9xr results on one patient.The results provided were: sid (b)(4).Initial result = 48.69 u/ml, repeated = 5.27 u/ml.It is unknown if the patient has been diagnosed with pancreatic cancer.No impact to patient management was reported.
 
Manufacturer Narrative
The complaint investigation included a search for similar complaints, and the review of complaint text, trending data, labeling, device history records and historical performance of reagent lot 14016m800.Return testing was not completed as returns were not available.Historical performance of reagent lot 14016m800 was evaluated using world wide data.Patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 14016m800 is inside the established control limits, which indicates acceptable product performance.A review of tracking and trending did not identify any trends for the complaint issue.Device history record review on lot 14016m800 did not identify any issues associated with the complaint issue.Labeling was reviewed and found to adequately address the issue of falsely elevated results.Based on the investigation no systemic issue or deficiency of the architect ca 19-9xr reagent lot 14016m800 was identified.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11003435
MDR Text Key221291325
Report Number3002809144-2020-01183
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 01/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/11/2021
Device Catalogue Number02K91-32
Device Lot Number14016M800
Was Device Available for Evaluation? No
Date Manufacturer Received01/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ARC I1000SR MOD, 01L86-01, I1SR62440; ARC I1000SR MOD, 01L86-01, I1SR62440; ARC I1000SR MOD, 01L86-01, I1SR62440
-
-