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

Catalog Number	03M74-84
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.No specific patient information was provided.
Event or Problem Description
The customer reported a (b)(6) architect anti-hbc ii results for 2 patients on the architect i2000sr analyzer.Sample id (b)(6): (b)(6) on an alternate analyzer.Sample id (b)(6): (b)(6) on an alternate analyzer.No adverse impact to patient management was reported.
Additional Manufacturer Narrative
The field service engineer inspected the analyzer and resolved the issue by replacing the manifold kit valve (rohs,) which was identified as likely cause.A review of the service history of the architect serial (b)(4) identified no additional contributing factors and no subsequent issues have been reported.A review of complaint and trending data for manifold kit valve (rohs) identified no issues or trends.A review of architect i2000sr tracking and trending data in the product monitoring review for architect systems revealed no systemic issues or adverse trends related to the erratic result issue described in this complaint.The architect i2000sr erratic result rate was reviewed and is within acceptable limits with no trends identified.Labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the architect i2000sr analyzer was identified.

• Brand Name: ARCHITECT I2000SR ANALYZER
• Common Device Name: AUTOMATED IMMUNOASSAY ANALYZER
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8201131
• Report Number: 1628664-2018-02194
• Device Sequence Number: 13492411
• Product Code: JJE
• UDI-Device Identifier: 00380740107222
• UDI-Public: 00380740107222
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K983212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 03M74-84
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/07/2018
• Supplement Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT ANTI-HBC II,; ARCHITECT ANTI-HBC II,; LIST 08L44-30, LOT 87077LI00; LIST 08L44-30, LOT 87077LI00