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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ARCHITECT I2000SR ANALYZER; AUTOMATED IMMUNOASSAY ANALYZER

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ABBOTT MANUFACTURING INC ARCHITECT I2000SR ANALYZER; AUTOMATED IMMUNOASSAY ANALYZER Back to Search Results
Catalog Number 03M74-01
Device Problems False Positive Result (1227); Incorrect Or Inadequate Test Results (2456)
Patient Problems No Consequences Or Impact To Patient (2199); Test Result (2695)
Event Date 02/12/2015
Event Type  malfunction  
Event Description
The customer stated that one patient sample generated a (b)(6), which was repeated (b)(6) the next day.A new sample from the same patient was also tested and (b)(6) results were generated.Both samples were then retested and (b)(6) results were generated.No impact to patient management was reported.
 
Manufacturer Narrative
(b)(4).Product evaluation is in process and the results will be submitted in a follow-up report.
 
Manufacturer Narrative
Product evaluation was performed in order to investigate this issue.Field service reviewed the instrument logs and found the temperature was irregular for the wash zone 1 and 2.As a result, the following parts were replaced and coded as being worn out from normal use: the wash zone 1 and 2 valves for a total of 8 valves.Two valve, vacuum two valve, drain, vacuum vessel one vacuum pump repair kit the parts referenced above were considered to have resolved the issue.Service history for the architect (b)(4) revealed no subsequent complaints of discrepant results.12 month search for similar complaints did not identify an adverse trend for the following parts replaced.No trends were identified for the referenced parts.The architect system operations manual addresses troubleshooting for the described issue.The b-hcg package insert addresses sample handling and performance characteristics.A single definitive cause of the issue was not identified.Field service replaced multiple parts through normal troubleshooting to resolve the issue.All parts were determined to be worn out from normal use.There is insufficient information to reasonably suggest a malfunction of the replaced parts.No product deficiency was identified.
 
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Brand Name
ARCHITECT I2000SR ANALYZER
Type of Device
AUTOMATED 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 Key4600829
MDR Text Key5464149
Report Number1628664-2015-00105
Device Sequence Number1
Product Code DHA
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K983212
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/19/2015
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 Catalogue Number03M74-01
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/23/2015
Initial Date FDA Received03/13/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/29/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2005
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
LOT NUMBER 41903UI01; ARCHITECT (B)(6); ARCHITECT (B)(6); LOT NUMBER 41903UI01
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