MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT HBSAG QUALITATIVE

Catalog Number	04P53-35
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A followup report will be submitted when the evaluation is complete.Evaluation in process.
Event or Problem Description
The account generated a reactive, confirmed positive architect hbsag qualitative result on a child.The account questioned the confirmed positive hbsag results as all other hepatitis markers were negative.No impact to patient management was reported.
Additional Manufacturer Narrative
Testing of panels which mimic patient samples using retained samples of the complaint lot 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.The complaint database was reviewed to determine if others have experienced the issue encountered at the customer facility.This review showed no adverse trend for the products over the last 12 months and normal complaint activity for the product lot.A review of the customer data showed consistent repeatedly reactive hbsag qualitative results for the sample id.Additionally, the patient tested non-reactive for ausab, core and core-m and no pcr testing was performed.Customer filed data was used to assess the specificity of the assay.The median patient result for likely cause lot was reviewed and is comparable to other lots in the field.A review of the product labeling concluded that the issue is sufficiently addressed.Based on all available information and the complaint investigation, the assay performed as intended and no product deficiency was identified.
Additional Manufacturer Narrative
The device evaluation was reassessed and concluded that a malfunction occurred, therefore, the device was not performing as intended at the customer site.However, no systemic issue and/or product deficiency was identified.The conclusion code was changed.

• Brand Name: ARCHITECT HBSAG QUALITATIVE
• Common Device Name: HBSAG
• Manufacturer (Section D): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• MDR Report Key: 5895276
• Report Number: 3008344661-2016-00058
• Device Sequence Number: 626685
• Product Code: KSJ
• UDI-Device Identifier: 00380740007782
• UDI-Public: (01)00380740007782(17)161011(10)61299FN00
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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,Followup,Followup
• Report Date (Section B): 06/15/2017

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: 10/11/2016
• Device Catalogue Number: 04P53-35
• Device Lot Number: 61299FN00
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/26/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/22/2016
• Supplement Report FDA Received Date: 10/07/2016; 06/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 6 YR