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

Catalog Number 02K91-23

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process. A follow up report will be submitted when the evaluation is complete.

Event Description

The customer observed falsely elevated imprecise ca19-9 results on the architect i2000sr analyzer. The following data was provided sid (b)(6): initial 49 u/ml, 66. 8, 45. 7, 54. 9 u/ml additional patient: initial 16. 3, repeat 6, 9, 6 u/ml there was no impact to patient management reported.

Manufacturer Narrative

On (b)(4) 2016 the suspect medical device was changed from 50363m500 to 50353m500. On (b)(4) 2016 additional patient data was provided: sid (b)(6) initial 46. 3, repeat 6. 3, 6. 4 u/ml. On (b)(4) 2016 additional patient data was provided: sid (b)(6) initial 197. 6 u/ml, repeat 283 u/ml. On (b)(4) 2016 after further evaluation, the suspect medical device was changed from ca19-9 reagents ln 02k91-23 lot 50353m500 manufactured in abbott (b)(4) to the architect i2000sr analyzer ln 03m74-02 sn (b)(4) manufactured in (b)(4). Mdr number 1628664-2016-00242 has been submitted and all further information will be documented under that mdr number.

• 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: 5910509
• MDR Text Key: 53485982
• Report Number: 1415939-2016-00090
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K052000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 09/26/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 02K91-23
• Device Lot Number: 50363M500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/29/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage