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	01/26/2019
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.Complete information for patient information, patient identifier: multiple = (b)(6).There is no further patient information provided by the customer.
Event or Problem Description
The customer reported (b)(6) architect (b)(6) results on five patients.The results provided were: on (b)(6) 2019 (b)(6); on (b)(6); on (b)(6).There was no reported impact to patient management.
Additional Manufacturer Narrative
After further evaluation, the suspect medical device was changed from: architect ausab, list number 01l82-27, and manufacturing site: abbott ireland, diagnostics division, finisklin business park, sligo na, irl, mailto: (b)(6), this report to: architect i1000sr analyzer, list number 01l86-01, and manufacturing site of abbott manufacturing inc, 1921 hurd drive, irving, tx 75038, usa.Mdr number 1628664-2019-00211 has been submitted and all further information will be documented under that mdr number.

• 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: 8343928
• Report Number: 3008344661-2019-00015
• Device Sequence Number: 1587764
• Product Code: LOM
• UDI-Device Identifier: 00380740115364
• UDI-Public: 00380740115364
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2019

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 Expiration Date: 09/18/2019
• Device Catalogue Number: 01L82-27
• Device Lot Number: 90007FN00
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/26/2019
• Supplement Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 03/15/2019
• 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 I1000SR ANALYZER, LN 01L86-01; ARCHITECT I1000SR ANALYZER, LN 01L86-01; SERIAL # I1SR04089; SERIAL # I1SR04089