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

Model Number N/A

Device Problem False Positive Result (1227)

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

Event Date 06/01/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported initial (b)(6) results on a patient while running on the alinity s system.The patient sample generated an initial result of (b)(6), repeat (b)(6).The customer centrifuged and retested the patient sample generating results of (b)(6) and (b)(6).There was no impact to patient management reported.

Manufacturer Narrative

There were no returns available.Ticket searches determined that there is normal complaint activity for the reagent lot 09201be00 and the tracking and trending report review determined that there are no related trends for this assay.A review of labeling concluded that the issue is sufficiently addressed.Device history records for the reagent lot did not identify any issues associated with the complaint issue.Clinical specificity testing was performed using a negative population panel and additional replicates of negative control with a retained kit of lot 09201be00.No false reactive results were obtained and all negative controls were within specifications indicating acceptable product performance.Based on this investigation, no systemic issue or deficiency of the alinity s htlv i/ii lot was identified.This report is being filed on an international product, list number 06p07-55 that has a similar product distributed in the us, list number 06p07-60.

• Brand Name: ALINITY S HTLV I/II REAGENT KIT
• Type of Device: HTLV-I/ HTLV-II ANTIBODIES
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10175447
• MDR Text Key: 197108174
• Report Number: 3002809144-2020-00490
• Device Sequence Number: 1
• Product Code: QHM
• 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: 06/30/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2020
• Device Model Number: N/A
• Device Catalogue Number: 06P07-55
• Device Lot Number: 09201BE00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/02/2020
• Initial Date FDA Received: 06/19/2020
• Supplement Dates Manufacturer Received: 06/24/2020
• Supplement Dates FDA Received: 06/30/2020
• 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)(6) ; SERIAL (B)(6)