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

Model Number	1L82-25
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 reagents.The following data was provided for one patient (miu/ml).(b)(6).Per the product package insert, when initial result is less than or equal to 8.00 to less than 12.00 miu/ml the interpretation is grayzone and instructs the user to retest in duplicate.Nonreactive results (less than 8.00 miu/ml) and reactive results (greater than or equal to 12.00 miu/ml) do not require retest.No impact to patient management was reported.
Additional Manufacturer Narrative
Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, device history review, labeling review, and specificity testing.No adverse trend was identified for the customer issue.Device history review did not identify any issues that may have caused the customer issue.Labeling was reviewed and found to be adequate.The product was not returned.No patient sample was available for return, therefore clinical specificity testing of calibrator a replicates was performed using in-house retained kits stored at the recommended storage condition.Specificity testing met all specifications.Based on all available information and abbott diagnostics evaluation, no systemic issue was identified and no product deficiency was found.

• 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: 6977588
• Report Number: 3008344661-2017-00092
• Device Sequence Number: 11100801
• Product Code: LOM
• UDI-Device Identifier: 00380740001513
• UDI-Public: (01)00380740001513(17)180601(10)74132FN00
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P050051
• 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
• Report Date (Section B): 11/20/2017

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: 06/01/2018
• Device Model Number: 1L82-25
• Device Catalogue Number: 01L82-25
• Device Lot Number: 74132FN00
• Initial Date Received by Manufacturer: 10/05/2017
• Supplement Date Received by Manufacturer: 11/19/2017
• Initial Report FDA Received Date: 10/25/2017
• Supplement Report FDA Received Date: 11/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1