MAUDE Adverse Event Report: ABBOTT LABORATORIES 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 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 observed an increase in (b)(6) prism hiv o plus results using cadaveric specimens.Four cadaveric specimens were prism hiv o plus repeatedly (b)(6) but confirmed (b)(6) by a reference lab.(b)(6).No specific patient information was provided.No impact to patient management was reported.
Additional Manufacturer Narrative
The evaluation of complaint data for the product and likely cause lots 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 likely cause lots.The irr, the rrr and the specificity of both lots are within package insert specifications.A review of labeling concluded that the issue is sufficiently addressed.No product deficiency was identified.

• Brand Name: 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: 8183454
• Report Number: 1415939-2018-00169
• Device Sequence Number: 11269004
• Product Code: MZF
• UDI-Device Identifier: 00380740062958
• UDI-Public: 00380740062958
• 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): 05/13/2019

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: 04/06/2019
• Device Catalogue Number: 03L68-68
• Device Lot Number: 90085M500
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/23/2018
• Supplement Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 12/20/2018
• Supplement Report FDA Received Date: 05/13/2019
• 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: LOT 88015M500; LOT 88015M500; PRISM LIST 06A36-34; PRISM LIST 06A36-34,; SERIAL (B)(4); SERIAL (B)(4)