MAUDE Adverse Event Report: ABBOTT GMBH ALINITY S ANTI-HCV REAGENT KIT

Model Number N/A

Device Problem False Negative Result (1225)

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

Event Date 06/01/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation included a review of complaint text, a search for similar complaints, review of historical data, sensitivity testing, and a review of labeling.No customer returns were available for review.The complaint review determined normal complaint activity for lot 09221be00.The tracking and trending review determined no trends related to the complaint issue.Sensitivity testing was performed with a retained kit of lot 09221be00 and two sensitivity panels ((b)(6) core only panel (panel a) and (b)(6) ns3 only panel (panel b)).The sensitivity panels met specifications and the results were in the typical range and no false non-reactive results were obtained.The seroconversion panel results of panels (zeptometrix hcv seroconversion panels (b)(6) 9045 and (b)(6) 9047) were compared to historical data of alinity s (b)(6) test results.The reagent lot 09221be00 detected the same bleeds as reactive with comparable s/co values for the seroconversion panels.Device history record review of the lot did not show any potential non-conformances, or deviations.A review of labeling was performed and found there to be adequate information.Based on the available information, no product deficiency was identified.Patient identifier: (b)(6).This report is being filed on an international product, list number 06p04-55 that has a similar product distributed in the us, list number 06p04-60.

Event Description

The customer reported false nonreactive alinity s (b)(6) results on 2 donors.The following data was provided (alinity s (b)(6) cutoff range: less than 1.00 s/co = nonreactive): donor code (b)(6): on (b)(6) 2020 alinity s initial result = 0.41 s/co.On (b)(6) 2020 alinity s initial result = 0.33 s/co.Other results provided: on (b)(6) 2020 cobas = initial =5.86, repeat = 5.96,6.87; on (b)(6) 2020 cobas result = 5.70, 4.47; (b)(6) rna pcr = undetectable; on (b)(6) 2020 (b)(6) blot innolia = positive.Donor code (b)(6): on (b)(6) 2020 alinity s initial result= 0.44 s/co.On (b)(6) 2020 alinity's initial result = 0.27 s/co.Other results provided: on (b)(6) 2020 cobas initial result = 15.55, repeat = 15.6,15.25; on (b)(6) 2020 cobas result = 18.36; on (b)(6) 2020 cobas result = 14.13; on (b)(6) 2020 cobas repeat result = 14.17; on (b)(6) 2020 cobas initial result (new sample) = 13.59; on (b)(6) 2020 (b)(6) rna pcr = undetectable; on (b)(6) 2020 (b)(6) blot innolia = positive.There was no impact to patient management reported.

• Brand Name: ALINITY S ANTI-HCV REAGENT KIT
• Type of Device: ANTI-HCV
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: christian lee ; 100 abbott park road; dept 09b9, bldg cp01-3; abbott park, IL 60064-3537 ; 224668-294
• MDR Report Key: 10279780
• MDR Text Key: 241305809
• Report Number: 3002809144-2020-00674
• Device Sequence Number: 1
• Product Code: QHM
• Combination Product (y/n): N
• Reporter Country Code: IR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/15/2020

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: 09/17/2020
• Device Model Number: N/A
• Device Catalogue Number: 06P04-55
• Device Lot Number: 09221BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2020
• Initial Date FDA Received: 07/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1