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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 12/05/2016
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 ca19-9 results on the architect i2000sr analyzer. The following data was provided: sid (b)(6) initial 127, repeat 15. 3 u/ml. There was no impact to patient management reported and no information regarding the patient diagnosis available.
 
Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling and accuracy testing. Historical performance of the reagent lot was evaluated using world wide data from abbott link. The patient data was analyzed and compared to an established control limit. This evaluation indicated that the patient median result for this lot is within the established control limits and no unusual reagent lot performance was identified. No adverse trend was identified for the customer's issue. Labeling was reviewed and found to be adequate. The product was not available for return. An internal panel was tested with retained kits of the likely cause reagent lot and accuracy testing met all specifications. Based on all available information and abbott diagnostics' complaint investigation, the assay performed as intended and no product deficiency was identified.
 
Manufacturer Narrative
The conclusion code was corrected. The device evaluation was reassessed and concluded that a malfunction occurred, therefore, the device was not performing as intended, however, no systemic issue or product deficiency was identified.
 
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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 Key6203353
MDR Text Key63260829
Report Number1415939-2016-00130
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,Followup
Report Date 04/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/05/2017
Device Catalogue Number02K91-38
Device Lot Number62025M800
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 Received04/20/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2016
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: 12/23/2016 Patient Sequence Number: 1
Treatment
ARCHITECT I2000SR ANALYZER; LN 03M74-01 SN (B)(4)
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