MAUDE Adverse Event Report: ABBOTT LABORATORIES PRISM HBSAG CONFIRMATORY

Catalog Number	06E51-68
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/11/2018
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 (b)(6), confirmed (b)(6) result on a plasma donor who tested (b)(6)(sample draw dates of (b)(6) 2018).Sid (b)(6) (sample draw date of (b)(6) 2018) tested prism (b)(6) initial, repeat and confirmed (b)(6).No impact to patient management was reported.The (b)(6) plasma unit was not released for use.No specific donor information provided.
Additional Manufacturer Narrative
Lot updated from unknown to 89057m500 on this report.Evaluation in process.
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 reactive rates, repeat reactive rates and specificity of the complaint lot numbers were within package insert specifications.No product deficiency was identified.

• Brand Name: PRISM HBSAG CONFIRMATORY
• Common Device Name: HBSAG CONFIRMATORY
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 7904081
• Report Number: 1415939-2018-00142
• Device Sequence Number: 169356
• Product Code: KSJ
• UDI-Device Identifier: 00380740062972
• UDI-Public: 00380740062972
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/19/2019

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: 05/21/2019
• Device Catalogue Number: 06E51-68
• Device Lot Number: 89057M500
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 09/25/2018; 01/25/2019
• Initial Report FDA Received Date: 09/24/2018
• Supplement Report FDA Received Date: 10/22/2018; 02/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HBSAG LIST 06D19-68, LOT 89034M500; HBSAG LIST 06D19-68, LOT 89034M500; HBSAG LIST 06D19-68, LOT 89034M500; PRISM LIST 06A36-04, SERIAL (B)(4); PRISM LIST 06A36-04, SERIAL (B)(4); PRISM LIST 06A36-04, SERIAL (B)(4)