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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 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.There was no further patient information provided by the customer.This report is being filed on an international product, list number 2k91-39 that has a similar product distributed in the us, list number 2k91-33.
 
Event Description
The customer reported falsely elevated architect ca19-9 results on one patient sample.The results provided were: initial ca19-9 = 202.2 / retest = < 2.The patient's disease state is unknown.There was no reported impact to patient management.
 
Manufacturer Narrative
A review of tickets for the architect ca19-9xr assay was performed.The review did not identify any trends that indicate a product issue related to patient results.A ticket review was completed for lot number 84019m800 and did not find an increase in complaints for the issue.Return testing was not completed as returns were not available.Historical performance of reagent lot 84019m800 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 lot 84019m800 is within the established control limits.Therefore, no unusual reagent lot performance was identified.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 architect ca19-9xr, lot number 84019m800.
 
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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 Key8024854
MDR Text Key125674103
Report Number3002809144-2018-00496
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 11/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/21/2018
Device Catalogue Number02K91-39
Device Lot Number84019M800
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/09/2018
Initial Date FDA Received10/31/2018
Supplement Dates Manufacturer Received11/08/2018
Supplement Dates FDA Received11/13/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ARCHITECT I2000SR ANALYZER, LIST # 03M74-01,; ARCHITECT I2000SR ANALYZER, LIST # 03M74-01,; SERIAL # (B)(4); SERIAL # (B)(4); ARCHITECT I2000SR ANALYZER, LIST # 03M74-01,; SERIAL # (B)(4).
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