MAUDE Adverse Event Report: ABBOTT LABORATORIES PRISM HBSAG

Catalog Number	06D19-68
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed a donor generated false repeat reactive, confirmed (b)(6) prism (b)(6) results.(b)(6) was prism hbsag repeat reactive and sent to a reference lab which generated confirmed (b)(6) results id (b)(6) (plasma bag aliquot from same donor) was prism (b)(6) repeat reactive and sent to the reference lab generating nonconfirming prism (b)(6) results.Additional donor testing was nat and anti-hbc negative.No impact to donor management was reported.
Additional Manufacturer Narrative
The evaluation of the customer issue included a search for similar complaints, a review of historical data and a review of labelling.Upon reviewing the likely cause lots, no adverse trend, non-statistical trends, non-conformances, potential non-conformances, or deviations were identified for the customer's issue.Labeling was reviewed and found to be adequate.Testing the sample with reagent lots and reference lots interpreted repeat reactive non-confirming result.Testing was performed using in-house retained kits and the testing met all specifications.Initial reactive rate, the repeat reactive rate and the specificity of complaint lot numbers were within package insert specifications.Based on the available information no product deficiency was identified.

• Brand Name: PRISM HBSAG
• Common Device Name: HBSAG
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 7802509
• Report Number: 1415939-2018-00120
• Device Sequence Number: 16621688
• Product Code: KSJ
• UDI-Device Identifier: 00380740062989
• UDI-Public: 00380740062989
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 01/25/2019

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: 12/05/2018
• Device Catalogue Number: 06D19-68
• Device Lot Number: 84014M500
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 01/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 23 YR