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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 02K91-39
Device Problem Low Test Results (2458)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/22/2021
Event Type  malfunction  
Manufacturer Narrative
Patient information: patient identifier
=
sid
=
(b)(6). (b)(4). Was this device serviced by a third party?: no. An evaluation is in process. A follow-up report will be submitted when the evaluation is complete.
 
Event Description
The customer observed falsely decreased when compare neat result to dilution result of architect ca 19-9xr results on one (b)(6) yr old female patient diagnosed with pancreatic head cancer. The results provided were: on (b)(6) 2021 sid (b)(4) 1200 ng/ml. 1:10 auto dilution
=
112. 24 ng/ml. 1:2 manual dilution
=
267. 47 ng/ml x 2
=
534. 94 ng/ml. 1:5 manual dilution
=
30. 11 and 15. 19 ng/ml x 5
=
150. 55 ng/ml and 75. 95 ng/ml. 1:10 manual dilution
=
11. 82 x 10
=
118. 20 ng/ml. This patient has previous history on (b)(6)
=
685. 8 ng/ml / (b)(6)
=
535. 7 ng/ml / (b)(6)
=
649. 1 ng/ml / (b)(6)
=
1151. 6 ng/ml / (b)(6)
=
812. 5 ng/ml there was no reported impact to patient management.
 
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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 Key11821665
MDR Text Key271109291
Report Number3002809144-2021-00311
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,Followup
Report Date 06/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/06/2021
Device Catalogue Number02K91-39
Device Lot Number19025M800
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 Received05/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/05/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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