MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT AUSAB; ANTI-HBS

Catalog Number	01L82-27
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/03/2018
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.
Event or Problem Description
The customer observed (b)(6) results while using the architect ausab assay.The customer indicated that on (b)(6) 2018, 8 patient specimens generated results between 20-30 miu/ml.None of the specimens have been retested.The customer believes the results may have been high since they were expecting (b)(6) results.The specimens were tested immediately after cap survey specimens that also generated high results, which were expected to be lower as well.No impact to patient management was reported.No specific patient information was provided.
Additional Manufacturer Narrative
Regarding date in date rec'd by mfr: on 10/19/2018; after further evaluation, the suspect medical device in question was changed from the architect ausab assay, list number 01l82, to the architect i2000sr analyzer, list number 03m74-02.Please see the following manufacture report number 1628664-2018-01963 further all information.An evaluation is in-process.

• Brand Name: ARCHITECT AUSAB
• Common Device Name: ANTI-HBS
• Manufacturer (Section D): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• MDR Report Key: 7793011
• Report Number: 3008344661-2018-00071
• Device Sequence Number: 16442903
• Product Code: LOM
• UDI-Device Identifier: 00380740115364
• UDI-Public: 00380740115364
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2018

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: 01L82-27
• Device Lot Number: 84103FN00
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/30/2018
• Supplement Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 08/17/2018
• Supplement Report FDA Received Date: 11/13/2018
• 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 I2000SR ANALYZER; ARCHITECT I2000SR ANALYZER; LN 03M74, SN (B)(4); LN 03M74, SN (B)(4)