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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 02K91-78
Device Problem Low Test Results (2458)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/12/2021
Event Type  malfunction  
Manufacturer Narrative
This report is being filed on an international product, list number 02k91-78 has a similar product distributed in the us, list number 2k91-33. The complaint investigation for falsely depressed architect ca 19-9xr results included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records. Return testing was not completed as returns were not available. Trending review did not identify any trends for the issue for the product. Device history record review on lot 22003m800 did not show any non-conformances, potential non-conformances, or deviations. Labeling was reviewed and found to adequately address the issue under review. The historical performance of reagent lot 22003m800 was evaluated using worldwide data. Patient data was analyzed and compared to an established control limit. This evaluation indicated that the patient median result for lot 22003m800 is inside the established control limits, which indicates acceptable product performance. Based on the investigation no systemic issue or deficiency of the architect ca19-9xr for lot number 22003m800 was identified.
 
Event Description
The customer observed falsely depressed architect ca 19-9xr results for one patient diagnosed with cancer. It is unknown which cancer the patient has been diagnosed with. The following data was provided: initial result in august
=
6232. 92 u/ml, repeat result correlated. Result in july
=
8. 93 u/ml. No impact to patient management was reported.
 
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Brand NameARCHITECT CA19-9XR REAGENT KIT
Type of DeviceSYSTEM, 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
Manufacturer (Section G)
ABBOTT GMBH
max-planck-ring 2
wiesbaden 65205
GM 65205
Manufacturer Contact
christian lee
100 abbott park road
dept. 09b9, lc cp01-3
abbott park, IL 60064-3537
2246682940
MDR Report Key12393502
MDR Text Key277709859
Report Number3002809144-2021-00539
Device Sequence Number1
Product Code NIG
Combination Product (y/n)N
Reporter Country CodeCH
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
Report Date 08/31/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/31/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/06/2021
Device Catalogue Number02K91-78
Device Lot Number22003M800
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/09/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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