MAUDE Adverse Event Report: ABBOTT LABORATORIES PRISM HBSAG

Catalog Number	06D19-68
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A followup report will be submitted when the evaluation is complete.
Event or Problem Description
The account generated a (b)(6) result on a donor who tested (b)(6), confirmed (b)(6).Data provided: donor 1 generated (b)(6) (34.34 s/co) and (b)(6) confirmatory (b)(6), but then generated (b)(6) (0.35 s/co) 5 days later.Donor 1 was a first time donor.The donor can donate plasma twice a week and both first and second plasma donations are held until the results from the first donation were reported.Donor 1 was then independently diagnosed with (b)(6) by a physician and believed to be truly (b)(6).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.
Additional Manufacturer Narrative
Ticket searches determined that there is a normal complaint activity for the likely cause lot and the tracking and trending report review determined that there are no related adverse and non-statistical trends identified.A retained reagent kit of the complaint lot was tested in a sensitivity setup.Results of this setup did not implicate that the sensitivity performance of the lot is negatively impacted.The reagent kit showed normal performance.The performance of the likely cause lot was investigated by completing a review for non-conformances, potential non-conformances and deviations related to the likely cause lot.This review did not identify any non-conformances, potential non-conformances or deviations.A review of labeling concluded that the issue is sufficiently addressed.A systemic issue and/or product deficiency was not identified.

• 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: 7431790
• Report Number: 1415939-2018-00078
• Device Sequence Number: 1544221
• 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,Followup
• Report Date (Section B): 06/04/2018

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
• Initial Date Received by Manufacturer: 03/22/2018
• Supplement Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 04/14/2018
• Supplement Report FDA Received Date: 06/04/2018
• 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: PRISM LIST 06A36-11; PRISM LIST 06A36-11, SERIAL (B)(4); SERIAL (B)(4)