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

Catalog Number	02K91-29
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer stated that a corrected report was required for architect ca 19-9xr testing for one patient being monitored to aid in cancer management.An initial result of 2911 u/ml was corrected to 2058 u/ml.No adverse impact to patient management was reported.
Additional Manufacturer Narrative
After further evaluation, the suspect medical device was changed from architect ca 19-9xr, list number 02k91-29, manufacturing site abbott (b)(4) of this report to architect i2000sr analyzer, list 03m74-02, manufacturing site irving, texas.Manufacturer report number 1628664-2017-00202 has been submitted and all further information will be documented under that number.

• Brand Name: ARCHITECT CA 19-9XR
• Common Device Name: CA 19-9
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 6497370
• Report Number: 1415939-2017-00042
• Device Sequence Number: 789305
• Product Code: NIG
• UDI-Device Identifier: 00380740105464
• UDI-Public: (01)00380740105464(17)170808(10)67007M800
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K052000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 02K91-29
• Device Lot Number: 67007M800
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/31/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/17/2017
• Supplement Report FDA Received Date: 05/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT I2000SR ANALYZER; LIST 03M74-02, SERIAL (B)(4)