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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GERMANY ARCHITECT CA 19-9XR CANCER ANTIGEN 19-9

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ABBOTT GERMANY ARCHITECT CA 19-9XR CANCER ANTIGEN 19-9 Back to Search Results
Catalog Number 02K91-32
Device Problem Low Test Results (2458)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/28/2017
Event Type  malfunction  
Manufacturer Narrative
The medical device manufacturer was incorrect in section for this issue. Mdr number 1415939-2017-00205 has been submitted and all further information will be documented under that mdr number.
 
Manufacturer Narrative
A review of complaint tracking and trending metrics was performed and identified no adverse trends in conjunction with the complaint issue currently under evaluation. No non-conformances or deviations associated with the affected reagent lot were identified. An in-house retained reagent kit of architect ca 19-9xr reagent, lot number 73036m800, was tested in an accuracy performance setup. Results from this testing did not implicate that the accuracy performance of the lot is negatively impacted. All acceptance criteria met specifications. No returns were made available from the customer site. The architect ca 19-9xr assay package insert contains information to address the current customer issue. Based on the results of this evaluation and the information from the customer site, no systemic issue or product deficiency was identified.
 
Manufacturer Narrative
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. This report is being filed on an international product, list number 02k91-32, that has a similar product distributed in the us, list number 02k91-29. Pt identifier: sid (b)(6).
 
Event Description
The customer reports the following results being generated with the architect ca 19-9xr assay for a patient diagnosed with pancreatic cancer and being monitored with samples tested on an architect i2000sr analyzer (the following results are from the same patient tested on (b)(6) 2017): sid (b)(6):1. 81 u/ml sid (b)(6):79. 96 u/ml sid (b)(6):61. 54 u/ml controls have remained within specifications. No suspect results have been reported from the lab. There is no impact to patient management reported.
 
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Brand NameARCHITECT CA 19-9XR
Type of DeviceCANCER ANTIGEN 19-9
Manufacturer (Section D)
ABBOTT GERMANY
max-planck-ring 2
wiesbaden 65205
GM 65205
Manufacturer (Section G)
ABBOTT GERMANY
max-planck-ring 2
wiesbaden 65205
GM 65205
Manufacturer Contact
noemi romero-kondos, rn bsn
100 abbott park road
dept. 09b9, lccp1-3
abbott park, IL 60064-3537
224667-512
MDR Report Key6791693
MDR Text Key249989144
Report Number3002809144-2017-00114
Device Sequence Number1
Product Code NIG
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/17/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/03/2018
Device Catalogue Number02K91-32
Device Lot Number73036M800
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 Received11/16/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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