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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 02K91-24
Device Problem Low Test Results (2458)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/21/2021
Event Type  malfunction  
Manufacturer Narrative
Patient identifier: multiple sids for one patient
=
(b)(6). An evaluation is in process. A follow-up report will be submitted when the evaluation is complete.
 
Event Description
The customer observed falsely depressed architect ca19-9xr results for one patient. The following data was provided: on (b)(6) 2021, sid (b)(6), initial ca 19-9xr result was 156. 89 u/ml, repeated >1200 u/ml, automatically diluted to 1:10 with a result of 10366 u/ml. On (b)(6) 2021, (same sample with new sid) sid (b)(6), initial result >1200 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 Key12605536
MDR Text Key278009520
Report Number3002809144-2021-00595
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
Report Date 12/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/11/2021
Device Catalogue Number02K91-24
Device Lot Number23013M800
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/06/2021
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

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