MAUDE Adverse Event Report: ABBOTT LABORATORIES ABBOTT PRISM HBSAG CONFIRMATORY ASSAY

Catalog Number	06E51-68
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete information for patient, patient identifier: (b)(6) an evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There is no further donor information provided due to privacy issues.
Event or Problem Description
The customer reported a false (b)(6) prism hbsag result on one donor.The results provided were: (b)(6) hbsag neat = 1.07s/co (>/=1.00s/co = (b)(6)) / repeat in duplicate = 1.11 / 1.14s/co.The sample had neutralizing confirmatory testing performed: 1.61s/co(>/=1.00s/co = (b)(6)) / retest = 1.57s/co / 1:500 = 0.54s/co (<1.00s/co = non(b)(6)) / 1.08s/co; undiluted 1.57s/co % neut = -4.62 (per the package insert additional dilution required); 1:500 dilution 1.08s/co % neut = 128.89 (confirmed (b)(6)).The samples tested (b)(6) for nat and (b)(6) for hbc.There was no reported impact to donor management.
Additional Manufacturer Narrative
Review of complaint activity associated with prism hbsag reagent lot number 03041m700 and prism hbsag confirmatory reagent lot number 96011m500 determined that there is normal complaint activity.Tracking and trending report reviewed and did not identify any trends.A review of labeling concluded that the issue is sufficiently addressed.Returns are not required as available field data are sufficient to review product performance.The customer field data were reviewed regarding initial reactive rates, repeat reactive rates and specificity for the prism, which were within package insert range.Historical review for non-conformances, potential non-conformances and deviations related to the lots and review did not reveal any issues with related lots.No product deficiency was identified for the prism hbsag reagent lot number 03041m700 and prism hbsag confirmatory reagent lot number 96011m500.

• Brand Name: ABBOTT PRISM HBSAG CONFIRMATORY ASSAY
• Common Device Name: HBSAG
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 8781729
• Report Number: 1415939-2019-00142
• Device Sequence Number: 14033685
• Product Code: KSJ
• UDI-Device Identifier: 00380740062972
• UDI-Public: 00380740062972
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2019

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: 12/10/2019
• Device Catalogue Number: 06E51-68
• Device Lot Number: 96011M500
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 07/11/2019
• Supplement Report FDA Received Date: 08/13/2019
• 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: LN 06D19-68, LOT # 03041M700; LOT # 03041M700; PRISM HBSAG, LN 06D19-68,; PRISM NEXT ANALYZER, LN 06A36-34; PRISM NEXT ANALYZER, LN 06A36-34, SN (B)(4); SERIAL # (B)(4), PRISM HBSAG