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

Catalog Number 06A53-48

Device Problem High Test Results (2457)

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

Event Date 07/11/2018

Event Type  malfunction  

Manufacturer Narrative

Patient identifier = sid (b)(6).An evaluation is in process.A final report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 6a53 that has a similar product distributed in the us, list number 6e50.There is no further donor information provided due to privacy issues.

Event Description

The customer reported (b)(6) prism htlv results on one sample during a correlation study.The results provided were: on prism on (b)(6) 2018 sid (b)(6) = (b)(6) / on (b)(6) 2018 = (b)(6); confirmatory testing was inconclusive.There was no reported impact to patient/donor management.

Manufacturer Narrative

The customer's attachments were reviewed and showed the complaint issue, but no further issues were identified.Since the lot number which was used for testing was unknown, no lot search could be performed.A review of the tracking and trending determined that there are no trends identified for prism htlv-i/htlv-ii, list number 6a53.A 12-month review of the performance of the prism htlv-i/htlv-ii, ln 6a53, was done and no events or issues that may have impacted the performance of the assay in relation to the complaint issue were identified.Return testing was not completed as returns were not available.Historical performance in the field of prism htlv-i/htlv-ii reagent lots using world wide data through abbottlink was evaluated.The initial reactive (ir) and repeat reactive (rr) rate was compared to the prism htlv-i/htlv-ii package insert specifications (irr: 0.07 % (95% ci: 0.02-0.17%); rrr: 0.06 % (95% ci: 0.02-0.15%); specificity: 99.96 % (95% ci: 99.87-99.99%).Even when assuming a zero prevalence of htlv-i/htlv-ii infection for the tested samples, the specificity of all lot numbers is within package insert specifications.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the prism htlv-i/htlv-ii assay.

• 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: 8413007
• MDR Text Key: 142394101
• Report Number: 1415939-2019-00016
• Device Sequence Number: 1
• Product Code: MTP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06A53-48
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRISM 6 CHANNEL ANALYZER, LN 06A36-04; PRISM 6 CHANNEL ANALYZER, LN 06A36-04; SERIAL # (B)(4); SERIAL # (B)(4)