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

Catalog Number 03M74-02

Device Problem Incorrect Or Inadequate Test Results (2456)

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.An evaluation is in process.

Event Description

The customer observed multiple falsely elevated b12 results while using the architect i2000sr analyzer.The following data was provided.The customer uses normal range 138 to 652 pmol/l.Patient 1 initial 152, repeat using another analyzer 93.Patient 2 initial 232, repeat using another analyzer 152.Patient 3 initial 146, repeat using another analyzer 95.No impact to patient management was reported.

Manufacturer Narrative

As part of troubleshooting, the customer replaced the r1 and r2 probes (part 08c94-42), recalibrated the assay, and reran the quality controls.System function was verified by performing a successful calibration as well as a precision run.No additional discrepant results were reported.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, instrument log 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 standard troubleshooting procedures.Service history review identified no contributing factors to the customer issue.A malfunction was identified as the device failed to meet performance specifications or otherwise perform as intended at the customer site.However, a systemic issue and/or product deficiency was not 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: 6577308
• MDR Text Key: 75521080
• Report Number: 1628664-2017-00223
• Device Sequence Number: 0
• Product Code: CDD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K983212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2017
• 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
• Date Manufacturer Received: 05/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2015
• 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
• Treatment: LIST NUMBER 07K61-35; LOT NUMBER 70195UI00