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U.S. Department of Health and Human Services

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

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ABBOTT GERMANY ARCHITECT CA 19-9XR Back to Search Results
Catalog Number 02K91-39
Device Problem Low Test Results (2458)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/27/2018
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There is no additional patient information provided due to privacy issues.This report is being filed on an international product list 2k91-39, that has a similar us product distributed in the us, list 2k91-33.Complete information for patient information: patient identifier = sid (b)(6).
 
Event Description
The customer reported falsely depressed architect ca19-9 results generated on one patient.The results provided were: historic ca19-9 = 66.2u/l; on (b)(6) 2018, sid (b)(6) = 11.25 / second test error code 3350 [measurement items cannot be processed for the second time.Suction error of (sample pipettor) with sample (sh sample)]; generated / third test = 13.31u/l.There was no reported impact to patient management.
 
Manufacturer Narrative
A review of tickets for lot 88046m800 was performed and did not identify an increase in complaints or any trends that indicate a product issue related to patient results.Historical performance of lot 88046m800 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 the lot is within the established control limits.Therefore, no unusual reagent lot performance was identified for lot 88046m800.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of labeling concluded that the issue is adequately addressed.Based on the investigation no product deficiency was identified for the architect ca 19-9xr reagent lot 88046m800.
 
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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
MDR Report Key8260610
MDR Text Key133859072
Report Number3002809144-2019-00018
Device Sequence Number1
Product Code NIG
Combination Product (y/n)N
PMA/PMN Number
K052000
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 02/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/09/2019
Device Catalogue Number02K91-39
Device Lot Number88046M800
Was Device Available for Evaluation? No
Date Manufacturer Received01/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ARCHITECT I2000SR ANALYZER, LN 03M74-01.; ARCHITECT I2000SR ANALYZER, LN 03M74-01.; SERIAL # (B)(4).; SERIAL # (B)(4).
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