MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT HBSAG QUALITATIVE CONFIRMATORY; HBSAG CONFIRMATORY

Catalog Number	04P54-25
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Historical quality metrics were reviewed and no adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.Complaint activity for the likely cause lot was determined to be normal.Testing of panels which mimic patient samples using in-house retained kits of lot 67302fn00 stored at the recommended storage condition was performed; all specifications were met indicating that the lot is performing acceptably.A review of the manufacturing documentation did not identify any issues associated with the customer observation.A malfunction was identified as the device failed to meet performance specifications or otherwise perform as intended at the customer site; however, no product deficiency was identified.
Event or Problem Description
The customer stated that a weak (b)(6) architect (b)(6) result was generated for a patient on (b)(6) 2017.The sample retested (b)(6) and confirmed (b)(6) using the architect (b)(6) qualitative confirmatory assay.The same patient was redrawn the following day and the result was (b)(6).The sample was sent to another laboratory and the result was (b)(6).No adverse impact to patient management was reported.

• Brand Name: ARCHITECT HBSAG QUALITATIVE CONFIRMATORY
• Common Device Name: HBSAG CONFIRMATORY
• Manufacturer (Section D): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• MDR Report Key: 6570019
• Report Number: 3008344661-2017-00043
• Device Sequence Number: 19058742
• Product Code: LOM
• UDI-Device Identifier: 00380740007799
• UDI-Public: (01)00380740007799(17)170429(10)67302FN00
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P110029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date (Section B): 05/16/2017

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 Expiration Date: 04/29/2017
• Device Catalogue Number: 04P54-25
• Device Lot Number: 67302FN00
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2017
• Initial Report FDA Received Date: 05/16/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT I2000SR ANALYZER; LIST 03M74-02, SERIAL (B)(4)