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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 02K91-23
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)(4): 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 additional patient data was provided: (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.
 
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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 Key5910506
MDR Text Key53375208
Report Number1415939-2016-00091
Device Sequence Number1
Product Code NIG
Combination Product (y/n)N
Reporter Country CodeFR
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 09/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number02K91-23
Device Lot Number50354M500
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 Received08/29/2016
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: 08/29/2016 Patient Sequence Number: 1
Treatment
LN 03M74-02, SN (B)(4)
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