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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 08P32-30
Device Problem Low Test Results (2458)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/29/2021
Event Type  malfunction  
Manufacturer Narrative
Patient identifier
=
(b)(6). All available patient information was included. No additional information was provided. An evaluation is in process. A follow-up report will be submitted when the evaluation is complete.
 
Event Description
The customer reported falsely depressed alinity i ca 19-9 results were generated for a patient. The following data was provided: sid (b)(6): initial result 82. 54 u/ml; retest result 128. 85 u/ml (shift of 56. 11%) no information was available as to if this patient was being monitored for pancreatic cancer. There was no reported impact to patient management.
 
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Brand NameALINITY I CA 19-9XR 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 Key11320807
MDR Text Key254391869
Report Number3002809144-2021-00100
Device Sequence Number1
Product Code NIG
Combination Product (y/n)N
Reporter Country CodeFR
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,Followup,Followup
Report Date 06/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/07/2021
Device Catalogue Number08P32-30
Device Lot Number20834FP00
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/06/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/15/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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