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Catalog Number 02K91-20
Device Problem False Positive Result (1227)
Patient Problems Misdiagnosis (2159); No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative
Architect ca 19-9xr assay lot numbers were not provided; therefore, historical performance of the architect ca 19-9xr assay was evaluated. Patient data was evaluated and compared to an established control limit. This evaluation concluded that patient median results for all reagent lots are within established control parameters. No unusual reagent lot performance was identified. A review of complaint tracking and trending metrics was performed and identified no related adverse trends in conjunction with the complaint issue currently under evaluation for this product. The architect ca 19-9xr assay package insert contains information to address the current customer issue. The statistical evaluation shows that the assay is performing to specifications. As documented in the journal article text, the medical procedures performed on the patient appeared to be solely based on the elevated architect ca 19-9xr assay results without utilizing other clinical evaluations and/or other diagnostic procedures in conjunction with the elevated architect ca 19-9xr results as required per the assay package insert. Also, per the assay package insert, results from the architect ca 19-9xr assay should not be compared to results obtained from other methods. Based on the results of this evaluation and the information from the customer site, a product malfunction was identified as the device failed to meet performance specifications or otherwise perform as intended at the customer site. However, 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. Literature reference: antunovic t, barhanovic ng, barac i. Enormous discrepancy between two ca 19-9 assays; case report. Clinical chemistry and laboratory medicine : cclm / fescc. Issn/isbn: 14346621. Year: 2017. Vol (iss) pgs: 55 (suppl 1) p. S381.
Event Description
A (b)(6) female patient diagnosed with urticaria generated an initial architect ca 19-9xr assay result of >1200 u/ml (dilutions were not performed). Cea, afp and ca 15-3 assay results were within normal reference ranges. After a gastroenterologist exam, she also underwent us exam of the abdomen, msct, egd, mri of the abdomen and a colonoscopy. All findings were within physiological limits. The ca 19-9xr was repeated with a result of 5199 u/ml. All markers were comparable on the roche cobas e601 analyzer, except for the ca 19-9 marker, which generated a result of 8. 25 u/ml. Liver function tests were normal along with negative serum immunofixation and negative hbsag and hcv. Igm was slightly elevated with rf within reference range and no proof of an autoimmune disease. Possible hook effect was eliminated as a possibility and peg precipitation showed a large discrepancy between the architect (5. 8 u/ml; recovery 0. 22%) and cobas (5. 2 u/ml; recovery 126. 06%) platforms. There is no further impact to the patient reported.
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Type of DeviceCA 19-9
Manufacturer (Section D)
100 abbott park road
abbott park IL 60064 3500
Manufacturer (Section G)
100 abbott park road
abbott park IL 60064 3500
Manufacturer Contact
noemi romero-kondos, rn bsn
100 abbott park road
dept. 09b9, lccp1-3
abbott park, IL 60064-3537
MDR Report Key6741028
MDR Text Key164069687
Report Number1415939-2017-00163
Device Sequence Number1
Product Code NIG
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2017
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue Number02K91-20
Device Lot NumberUNKNOWN
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 Received08/04/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 07/25/2017 Patient Sequence Number: 1