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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GMBH ALINITY I CA 19-9XR REAGENT KIT; SYSTEM, TEST, CARBOHYDRATE AG (CA19-9), FOR MONIT AND MGMT OF PANCREATIC CANCER
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ABBOTT GMBH ALINITY I CA 19-9XR REAGENT KIT; SYSTEM, TEST, CARBOHYDRATE AG (CA19-9), FOR MONIT AND MGMT OF PANCREATIC CANCER Back to Search Results
Catalog Number 08P32-20
Device Problem High Test Results (2457)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
 
Event Description
The customer obtained a falsely elevated alinity i ca19-9xr result.Sample id: (b)(6)generated an initial result of 74.59 u/ml.The sample was retested and generated 2.93, and 4.23 u/ml.The customer further indicated the patient's previous result (b)(6) 2020 was 3.02 u/ml.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 accuracy testing of reagent lot 14665fp00.Return testing was not completed as returns were not available.Review of complaint activity and trending data did not identify any issues or trends.Device history review for lot 14665fp00 did not identify any issues.Labeling was reviewed and sufficiently addresses the customer issue.Accuracy testing was performed using a retained kit of reagent lot 14665fp00.An internal alinity i ca19-9xr panel which was tested with the complaint lot.Acceptance criteria were met, which indicates acceptable product performance.Based on the investigation no systemic issue or deficiency of the alinity i ca19-9xr lot was identified.
 
Event Description
The customer obtained a falsely elevated alinity i ca19-9xr result.Sample id (b)(6) generated an initial result of 74.59 u/ml.The sample was retested and generated 2.93 and 4.23 u/ml.The customer further indicated the patient's previous result (b)(6) was 3.02 u/ml.No impact to patient management was reported.
 
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Brand Name
ALINITY I CA 19-9XR 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 Key10739501
MDR Text Key213188796
Report Number3002809144-2020-01055
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 12/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/06/2021
Device Catalogue Number08P32-20
Device Lot Number14665FP00
Was Device Available for Evaluation? No
Date Manufacturer Received12/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ALNTY I PROCESSING MODU, 03R65-01, AI03421; ALNTY I PROCESSING MODU, 03R65-01, AI03421; ALNTY I PROCESSING MODU, 03R65-01, AI03421
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