MAUDE Adverse Event Report: ABBOTT LABORATORIES ABBOTT PRISM HIV O PLUS; HIV-1 AND HIV-2 ANTIBODIES

Catalog Number	03L68-68
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/09/2019
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.All available donor information was included.Additional donor details are not available.Patient identifier: complete sid: (b)(6).
Event or Problem Description
The customer reported a (b)(6) prism hiv o plus result on one donor.Initial testing was (b)(6).Repeat result provided: (b)(6) 2019 sid (b)(6) = (b)(6); sample was nat testing (b)(6).Previous same donor tested on (b)(6) 2019 sid (b)(6) was (b)(6).No impact to donor management was reported.
Additional Manufacturer Narrative
The evaluation of complaint data for the product and likely cause abbott prism hiv o plus lot 02010n100 identified normal complaint activity.No customer returns were available for evaluation.The performance of the likely cause lots were investigated by completing a review for non-conformances, potential non-conformances and deviations related to the likely cause lots.This review did not identify any non-conformances, potential non-conformances or deviations.A review of overall customer field data was performed regarding initial reactive rate (irr), repeat reactive rate (rrr) and specificity for lot 02010n100.The irr, the rrr and the specificity of all lots are within package insert specifications.A review of labeling concluded that the issue is sufficiently addressed.No product deficiency was identified.

• Brand Name: ABBOTT PRISM HIV O PLUS
• Common Device Name: HIV-1 AND HIV-2 ANTIBODIES
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 9285679
• Report Number: 1415939-2019-00217
• Device Sequence Number: 155526
• Product Code: MZF
• UDI-Device Identifier: 00380740062958
• UDI-Public: 00380740062958
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2019

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: 11/27/2019
• Device Catalogue Number: 03L68-68
• Device Lot Number: 02010N100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 11/18/2019
• 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: PRISM 6 CHANNEL ANALYZER LIST 06A36-04; PRISM 6 CHANNEL ANALYZER LIST 06A36-04; SERIAL (B)(4); SERIAL (B)(4)