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

Catalog Number 03M74-02

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2017

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

He customer questioned an architect total psa result of 1.218 ng/ml for a patient because it was not compatible with the free psa result of 2.317 ng/ml.The sample retested at 10.521 and 10.383 ng/ml for total psa which matched the repeat free psa results of 2.052 and 2.053 ng/ml.The falsely decreased initial total psa result of 1.218 ng/ml was not reported out of the laboratory.The sample probe was cleaned to resolve the imprecision issue.No adverse impact to patient management was reported.

Manufacturer Narrative

Service performed various troubleshooting measures relative to the discrepant total psa result.Service observed the system generated error code 5000 - limited movement (sample pipettor) at (sh sample) step number (8925), immediately after pipetting the free psa assay, and several 3350 errors prior to pipetting the total psa assay.Service determined the probe (list number 08c94-42) was the likely cause of the issue.A review of (b)(4) service history identified no contributing factors on or around the date of the complaint, and there have been no subsequent contacts from the customer regarding erratic/discrepant results since service cleaned the probe to resolve the issue.Historical quality metrics were reviewed and no adverse trend was identified.Labeling was reviewed and found to be adequate.Based on the available information, 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: 6880455
• MDR Text Key: 87467594
• Report Number: 1628664-2017-00348
• Device Sequence Number: 0
• Product Code: LTJ
• 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,health professional
• Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03M74-02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2017
• Initial Date FDA Received: 09/20/2017
• Supplement Dates Manufacturer Received: 10/13/2017
• Supplement Dates FDA Received: 10/17/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1