MAUDE Adverse Event Report: ABBOTT LABORATORIES PRISM HBSAG CONF; PRISM HBSAG CONFIRMATORY

Catalog Number	06E51-68
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/18/2017
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 reported multiple (b)(6) results.Three plasma donation samples were repeat (b)(6) for prism hbsag and confirmed (b)(6) by the prism hbsag confirmatory assay.However, the samples were (b)(6) with the roche nat assay.The customer further indicated each donor was (b)(6) prior to the (b)(6) result and the subsequent donation (2 to 4 days later) were also (b)(6).No specific donor information was provided.No adverse impact to donor management was reported.Sample ids tested with confirmatory reagent lot 75067m500: (b)(6).
Additional Manufacturer Narrative
Further investigation of the issue included a review of the complaint text, a search for similar complaints, review of customer instrument logs, review of field data and a review of labeling.Review of complaint activity did not identify any adverse or non-statistical trends for the prism hbsag assay or the prism hbsag confirmatory assay.Normal complaint activity was identified for the likely cause lot.A review of the device history record for the likely cause lot did not reveal any issues related to the customer's observation.A review of the data generated by the customer for the prism hbsag assay was performed.This review included a comparison of initial and repeat (b)(6) rates for each lot to the package insert claims as well as a comparison to other masterlots within a similar timeframe.The customers initial and repeat (b)(6) rates were not (b)(6) and were within package insert claims.The performance of the complaint lots was similar to other lots.The prism hbsag and prism hbsag confirmatory reagent package inserts were reviewed and were found to adequately address the issue.Based on the results of this investigation no systemic issue or deficiency of the prism hbsag and hbsag confirmatory assays was identified.

• Brand Name: PRISM HBSAG CONF
• Common Device Name: PRISM HBSAG CONFIRMATORY
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 7221647
• Report Number: 1415939-2018-00012
• Device Sequence Number: 2248221
• Product Code: KSJ
• UDI-Device Identifier: 00380740062972
• UDI-Public: 00380740062972
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/02/2018

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: 03/07/2018
• Device Catalogue Number: 06E51-68
• Device Lot Number: 75067M500
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/04/2018
• Supplement Date Received by Manufacturer: 02/22/2018
• Initial Report FDA Received Date: 01/26/2018
• Supplement Report FDA Received Date: 03/02/2018
• 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: AND 77050M500; AND LOT 77050M500; PRISM ANALYZER, LIST 06A36-04 SN (B)(4); PRISM ANALYZER, LIST 06A36-04 SN (B)(4),; PRISM HBSAG 06D19-68 LOT 75124M500; PRISM HBSAG 06D19-68 LOT 75124M500