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 Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ticket searches determined that there is a normal complaint activity for the likely cause lots and the tracking and trending report review determined that there are no related adverse and non-statistical trends for the two mentioned assays.A review of labeling concluded that the issue is sufficiently addressed.The performance of the likely cause lots was investigated by completing a review for non-conformances, potential non-conformances and deviations related to the likely cause lots.This review did not reveal any events or issues that may have impacted the performance of the lot numbers in relation to the complaint issue.A review of field data was performed for the prism hbsag assay.The initial (b)(6) rate, repeat (b)(6) rate and the specificity were within package insert specifications.A product deficiency was not identified.
Event or Problem Description
The account stated a donor generated (b)(6) prism hbsag (b)(6), confirmed (b)(6) with prism hbsag confirmatory results.Data provided: donor 2 generated prism hbsag (b)(6)) and confirmed (b)(6) confirmatory (b)(6) using a different sample from the same draw.A second blood draw generated (b)(6) prism hbsag results.No plasma units were released for use and the donor is deferred from further donation.No impact to patient/donor management was reported.No specific donor information was provided.

• 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: 7423594
• Report Number: 1415939-2018-00075
• Device Sequence Number: 13464952
• Product Code: KSJ
• UDI-Device Identifier: 00380740062989
• UDI-Public: (01)00380740062989(17)180928(10)82004M500
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Report Date (Section B): 04/11/2018

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: 09/28/2018
• Device Catalogue Number: 06D19-68
• Device Lot Number: 82004M500
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 04/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1