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

Catalog Number 02K91-23

Device Problem High Test Results (2457)

Patient Problem No Code Available (3191)

Event Date 07/02/2017

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.(b)(4).

Event Description

The customer stated that erroneous architect ca 19-9xr results of 614.30 and 856.39 u/ml were generated for a patient (same sample) on (b)(6) 2017.A different sample from the same patient was tested on (b)(6) 2017 and the results were 729.99 and 708.62 u/ml.The physician disagreed with the result of 856.39 u/ml.Additional patient information was later provided.The patient was redrawn on (b)(6) 2017.The architect ca 19-9xr result was 42 u/ml (retest 46.42 u/ml).The patient is an (b)(6) male being monitored yearly following diagnosis of colon cancer 20 years ago.The patient underwent gastroscopy and colonoscopy based on the elevated architect ca 19-9xr values.The results showed normal findings including bile ducts and pancreas.The lower ca 19-9xr results of 42 and 46.42 u/ml more closely matched the patient's clinical history of low values.The patient is in good condition.No patient injury was reported due to the procedures performed.

Manufacturer Narrative

It was discovered on september 20, 2017 that the initial emdr for this issue was submitted under the correct suspect medical device but incorrect manufacturer name, city and state.Mdr number 1415939-2017-00183 has been submitted for the correct manufacturing site 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 GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• 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: 6815156
• MDR Text Key: 83747299
• Report Number: 3002809144-2017-00118
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K052000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02K91-23
• Device Lot Number: 67005M800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other