MAUDE Adverse Event Report: ABBOTT GERMANY ALINITY S HTLV I/II REAGENT KIT; HTLV-I/ HTLV-II ANTIBODIES

Catalog Number 06P07-55

Device Problem False Positive Result (1227)

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

Event Type  malfunction  

Manufacturer Narrative

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, alinity s htlv i/ii, list 6p07-55, that has a similar product distributed in the us, list number 6p07-60.Patient information: no further donor information was provided.Patient identifier: multiple = (b)(6) refer to related manufacturer report number 3002809144-2019-00852 for the device evaluation of reagent lot 01139be00.

Event Description

The customer reported multiple false repeat reactive alinity s htlv i/ii results.The customer indicated the samples were negative on western blot.No impact to donor management was reported.

Manufacturer Narrative

Review of complaint activity determined there was normal complaint activity for the alinity s htlvi/ii reagent, lot numbers 01139be00 and 01495be00.Tracking and trending report was reviewed and determined there are no related trends.Field data was reviewed regarding initial reactive rate (irr), repeat reactive rate (rrr) and specificity for lot numbers 01139be00 and 01495be00.For both lot numbers the irrs for total donors samples are outside the package insert specifications; however, the irrs are within the specifications both for donors - plasma and serum samples.The sample type tested by the customer was plasma.The repeat reactive rates for both lot numbers met specifications for total donors.Assuming a zero prevalence of htlv infections for the tested samples, the specificity is calculated to be 99.95 % for lot 01139be00 and 99.96 % for lot 01495be00, which is within package insert.Retained reagent kits of alinity s htlv i/ii reagent, lot numbers 01139be00 and 01495be00 were calibrated and the calibrations met instrument specifications; all control values met control specifications and were in the typical range.To evaluate clinical specificity of lots 01139be00 and 01495be00, a human negative population panel was tested.The results were in the typical range and no false reactive results were obtained.Furthermore, additional replicates of the negative control were tested which all met specifications.Manufacturing documentation was reviewed and no issues were identified.Additionally, labeling was reviewed and sufficiently addresses the customer issue.Based on the investigation, no systemic issue or deficiency was identified for the alinity s htlv i/ii reagent.

• Brand Name: ALINITY S HTLV I/II REAGENT KIT
• Type of Device: HTLV-I/ HTLV-II ANTIBODIES
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9305756
• MDR Text Key: 219782647
• Report Number: 3002809144-2019-00853
• 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: 12/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2020
• Device Catalogue Number: 06P07-55
• Device Lot Number: 01495BE00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY S SYSTEM, LIST 06P16-01,; ALINITY S SYSTEM, LIST 06P16-01,; SERIAL (B)(4) ; SERIAL (B)(4)