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U.S. Department of Health and Human Services

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

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ABBOTT LABORATORIES ARCHITECT CA 19-9XR Back to Search Results
Catalog Number 02K91-38
Device Problem High Test Results (2457)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/07/2016
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process. A follow up report will be submitted when the evaluation is complete. Note: this is the same patient that was reported in manufacturer report number 1628664-2016-00318 under a different suspect medical device.
 
Event Description
The customer observed a falsely elevated ca19-9 result on the architect i2000sr analyzer. The following data was provided for a patient with an unknown diagnosis: sid (b)(4) initial 45. 81, repeat 3. 5 u/ml. There was no impact to patient management reported. The buffer pump pn (b)(4) was replaced following these results.
 
Manufacturer Narrative
After further evaluation, on 12/29/2016 the suspect medical device was changed from architect ca19-9 reagents ln 02k91-38 lot 64023m800 manufactured at (b)(4) to the architect i2000 analyzer ln 08c89-01 sn (b)(4) manufactured at (b)(4). Mdr number 1628664-2016-00318 has been submitted and all further information will be documented under that mdr number.
 
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Brand NameARCHITECT CA 19-9XR
Type of DeviceCA 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 Key6206401
MDR Text Key63365412
Report Number1415939-2016-00131
Device Sequence Number1
Product Code NIG
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K052000
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number02K91-38
Device Lot Number64023M800
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 Received12/29/2016
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

Patient Treatment Data
Date Received: 12/27/2016 Patient Sequence Number: 1
Treatment
ARCHITECT I2000 ANALYZER; LN (B)(4) SN (B)(4)
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