MAUDE Adverse Event Report: ABBOTT LABORATORIES PRISM HTLV-I/HTLV-II; HTLV-I/ HTLV-II ANTIBODIES

Catalog Number 06E50-68

Device Problem False Positive Result (1227)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/09/2019

Event Type  malfunction  

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 Description

The customer reported a false repeat reactive prism htlv i/htlv ii result on one donor.Initial testing was reactive.Repeat result provided: (b)(6) 2019 sid (b)(6) = 1.34 s/co; sample was nat and western blot negative.Previous same donor tested on (b)(6) 2019 sid (b)(6) was nonreactive.No impact to donor management was reported.

Manufacturer Narrative

The evaluation of complaint data for the product and likely cause abbott prism htlv-i/htlv-ii lot 01114n100 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 01114n100.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: PRISM HTLV-I/HTLV-II
• Type of Device: HTLV-I/ HTLV-II ANTIBODIES
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 9285676
• MDR Text Key: 220143448
• Report Number: 1415939-2019-00216
• Device Sequence Number: 1
• Product Code: MTP
• UDI-Device Identifier: 00380740063016
• UDI-Public: 00380740063016
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2020
• Device Catalogue Number: 06E50-68
• Device Lot Number: 01114N100
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRISM 6 CHANNEL ANALYZER LIST 06A36-04; PRISM 6 CHANNEL ANALYZER LIST 06A36-04; SERIAL (B)(4); SERIAL (B)(4)