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	03/02/2018
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.(b)(6).
Event or Problem Description
The customer reports that another lab sends them their repeat (b)(6) samples for confirmatory neutralization testing with the abbott prism hbsag confirmatory assay.On (b)(6) 2018, sample (b)(6) that generated repeat (b)(6) results at the other lab generated confirmatory neutralization assay results of (b)(6) with the abbott prism hbsag confirmatory assay.The sample tested (b)(6) by a (b)(6) nat method and was (b)(6).No suspect results were reported from the lab.There is no impact to donor management reported.
Additional Manufacturer Narrative
A review of complaint tracking and trending metrics was performed and identified no related adverse or non-statistical trends in conjunction with the complaint issue currently under evaluation.No non-conformances, potential non-conformances or deviations were found, which may have impacted the performance of the product.A review of field data was performed.A total of 1,909,125 samples have been tested with prism hbsag reagent lot 82069m500 across different customer sites.This number of samples is greater than the minimum sample size of the assay package insert (25,238).The number of initial reactive results is 1,085 and the number of repeat reactive results is 212.The initial reactive rate: 0.06% (higher 95% confidence interval within package insert: 0.09%).The repeat reactive rate: 0.01% (higher 95% confidence interval within package insert: 0.06%).Assuming a zero prevalence of hbsag in the tested samples, the specificity is calculated to be 99.99%, which is within package insert specifications of 99.99% with a 95% confidence interval of 99.97% to 100.00%.Both the initial and repeat reactive rates as well as the specificity are within assay package insert specifications.The prism hbsag assay package insert provides information to address the current customer issue.Based on the available information from the customer site and the results of this evaluation, there is no evidence to reasonably suggest that a systemic issue or product deficiency exists.

• 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: 7387619
• Report Number: 1415939-2018-00066
• Device Sequence Number: 10795287
• Product Code: KSJ
• UDI-Device Identifier: 00380740062989
• UDI-Public: 00380740062989
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 04/09/2018

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: 82069M500
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2018
• Supplement Date Received by Manufacturer: 04/06/2018
• Initial Report FDA Received Date: 03/31/2018
• Supplement Report FDA Received Date: 04/09/2018
• 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: ABBOTT PRISM ANALYZER LN: 06A36-04; ABBOTT PRISM ANALYZER LN: 06A36-04; SN: (B)(4); SN: (B)(4)