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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ARCHITECT I1000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER

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ABBOTT MANUFACTURING INC ARCHITECT I1000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER Back to Search Results
Catalog Number 01L86-01
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/23/2017
Event Type  malfunction  
Manufacturer Narrative
An abbott field service engineer was dispatched to the account and found the analyzer wash cup baffle was dirty. The baffle, wash cup [part 01p41-01] was considered to by the likely cause of the issue and was replaced. The analyzer was returned to normal operation. Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, a labeling review, and an instrument service review. No returns were made available from the customer site for this evaluation. No adverse trend was identified for the customer issue. Labeling was reviewed and found to be adequate. The issue was resolved through the replacement of the part [baffle, wash cup part 01p41-01]. Service history review identified no contributing factors to the customer issue. Based on all available information and abbott diagnostics complaint investigation, no systematic issue was found and no product deficiency was identified.
 
Manufacturer Narrative
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. This issue was previously reported under mdr number 3008344661-2017-00080 under a different suspect device.
 
Event Description
The customer observed falsely elevated alpha-fetoprotein (afp) results while using the architect i1000 sr analyzer. The following data was provided. (b)(6). The patient is a child that was diagnosed with immature teratoma of the retroperitoneal space and was treated in 2015. The patient was being monitored after treatment of germogenic tumors. No adverse impact to patient management was reported.
 
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Brand NameARCHITECT I1000SR ANALYZER
Type of DeviceAUTOMATED IMMUNOASSAY ANALYZER
Manufacturer (Section D)
ABBOTT MANUFACTURING INC
1921 hurd drive
irving TX 75038
Manufacturer (Section G)
ABBOTT MANUFACTURING INC
1921 hurd drive
irving TX 75038
Manufacturer Contact
noemi romero-kondos, rn bsn
100 abbott park road
dept. 09b9, lccp1-3
abbott park, IL 60064-3537
224667-512
MDR Report Key6887699
MDR Text Key253682250
Report Number1628664-2017-00353
Device Sequence Number0
Product Code LOJ
Combination Product (y/n)N
Reporter Country CodeRS
PMA/PMN Number
EXEMPT
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 10/05/2017
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received09/22/2017
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number01L86-01
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 Received10/04/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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