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

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.

• 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 Key: 4600829
• MDR Text Key: 5464149
• Report Number: 1628664-2015-00105
• Device Sequence Number: 1
• Product Code: DHA
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K983212
• Number of Events Reported: 1
• 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 Number: 03M74-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/23/2015
• Initial Date FDA Received: 03/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LOT NUMBER 41903UI01; ARCHITECT (B)(6); ARCHITECT (B)(6); LOT NUMBER 41903UI01