MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT CA 19-9XR

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

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.

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.

• Brand Name: ARCHITECT CA 19-9XR
• Type of Device: CA 19-9
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• Manufacturer (Section G): ABBOTT LABORATORIES; 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 ; 224667-512
• MDR Report Key: 6741028
• MDR Text Key: 80949243
• Report Number: 1415939-2017-00163
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• PMA/PMN Number: K052000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02K91-20
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2017
• Initial Date FDA Received: 07/25/2017
• Supplement Dates Manufacturer Received: 08/04/2017
• Supplement Dates FDA Received: 08/04/2017
• 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: N
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER; LN: 03M74-02 SN: (B)(4)
• Patient Outcome(s): Other
• Patient Age: 47 YR