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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 Low Test Results (2458)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/16/2021
Event Type  malfunction  
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 25010fp00. A review of tracking and trending did not identify any trends for the complaint issue. Device history record review did not identify any issues associated with lot 25010fp00 and the complaint issue. Historical performance was evaluated using worldwide field data. Patient data was analyzed and compared to an established control limit. This evaluation indicated that the patient median result for lot 25010fp00 is inside the established control limits, which indicates acceptable product performance. Labeling was reviewed and found to adequately address the issue under review. Based on the investigation, no systemic issue or deficiency of the alinity i ca 19-9xr reagent lot 25010fp00 was identified.
 
Event Description
The customer observed a falsely depressed alinity i ca 19-9 result for a (b)(6) year-old female patient with suspected pancreatic head cancer, receiving chemotherapy with abraxane and gemcitabine. The following data was provided: initial result (undiluted) >1200 u/ml, automatic dilution 1800 u/ml. The physician questioned the result indicating that it was falsely depressed. The previous value was about 6000 u/ml. Automatic dilution was retested multiple times, stable at about 3000 u/ml, manual dilution was about 6000 u/ml. No impact to patient management was reported.
 
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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 Key12414180
MDR Text Key277714688
Report Number3002809144-2021-00551
Device Sequence Number1
Product Code NIG
Combination Product (y/n)N
Reporter Country CodeJA
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 09/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/11/2021
Device Catalogue Number08P32-20
Device Lot Number25010FP00
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 Received08/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/17/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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