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

Catalog Number	03M74-98
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling and instrument service.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.The issue was resolved through standard troubleshooting procedures.A malfunction of the probe was identified as the device failed to meet performance specifications or otherwise perform as intended at the customer site.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.
Event or Problem Description
The customer observed a false positive b-hcg result on the architect i2000sr analyzer.The following data was provided: initial 66.7, repeated on this instrument and another instrument, both results came out as < 2.0 result unit is miu/ml.There was no impact to patient management reported.

• 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: 6516587
• Report Number: 1628664-2017-00136
• Device Sequence Number: 884735
• Product Code: JJE
• UDI-Device Identifier: 00380740068851
• UDI-Public: 00380740068851
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K983212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2017

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: 03M74-98
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2017
• Initial Report FDA Received Date: 04/24/2017
• 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 B-HCG REAGENTS; LN 07K78-30 LOT 52900UI00