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

Catalog Number 02K91-24

Device Problem High Readings (2459)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Sex: (b)(6) is a (b)(6) female; (b)(6) is a (b)(6) male; (b)(6) is a (b)(6) female.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There is no further patient information provided due to privacy issues.This report is being filed on an international product, list number 2k91-24 that has a similar product distributed in the us, list number 2k91-33.

Event Description

The customer reported falsely elevated architect ca 19-9 results on 3 patients between neat and dilution testing.The results provided were: on (b)(6) 2018 (b)(6) neat = 319.72u/ml / dilution 152.00u/ml; (b)(6) 2018 (b)(6) neat = 206.55 / dilution = 93.86u/ml; on (b)(6) 2018 (b)(6) neat = 814.49u/ml / dilution = 314.820u/ml.Follow-up samples from these patients showed similar results.These samples were sent to outside labs where alternative methods (roche and siemens) produced agreement between neat and dilution results.There was no reported impact to patient management.

Manufacturer Narrative

A review of tickets determined no additional complaints were identified for the architect ca19-9xr, lot 79030m800, and no trends were identified related to patient results for the assay.Return testing was not completed as returns were not available.Historical performance of architect ca19-9xr, lot 79030m800, was evaluated using world wide data from abbott link.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 79030m800 is within the established control limits, therefore, no unusual reagent lot performance was identified.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of labeling concluded that the issue is adequately addressed.Based on the investigation no product deficiency was identified for architect ca19-9xr, lot 79030m800.

• Brand Name: ARCHITECT CA 19-9XR
• Type of Device: CA 19-9
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 7841624
• MDR Text Key: 119047867
• Report Number: 3002809144-2018-00299
• 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
• Type of Report: Initial,Followup
• Report Date: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2018
• Device Catalogue Number: 02K91-24
• Device Lot Number: 79030M800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER, LIST # 03M74-02,; ARCHITECT I2000SR ANALYZER, LIST # 03M74-02,; SERIAL # (B)(4); SERIAL # (B)(4); ARCHITECT I2000SR ANALYZER, LIST # 03M74-02,; SERIAL # (B)(4)