MAUDE Adverse Event Report: ABBOTT GMBH ALINITY S HIV AG/AB COMBO; HIV-1 AND HIV-2 ANTIBODIES

Catalog Number 06P01-55

Device Problem False Positive Result (1227)

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

Event Date 05/08/2020

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: complete entry = r000120057667r.Patient information: no specific patient/donor information was provided.This report is being filed on an international product, alinity s (b)(6) ag/ab combo, list 6p01-55, that has a similar product distributed in the us, list number 6p01-60.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported a false repeat reactive alinity s (b)(6) ag/ab combo assay.Sample id (b)(6) generated 67.24, 65.52 and 70.08 s/co.The sample generated negative results at nvrl for (b)(6) ultra and genscreen ultra (b)(6).The sample was also non-reactive at nat testing laboratory at ibts.No adverse impact to donor management was reported.

Manufacturer Narrative

Ticket searches for reagent lot 12175be00 determined that there was normal complaint activity.Tracking and trending report review determined that there were no related trends for the alinity s hiv ag/ab combo assay.The data provided by the customer was reviewed which included the s/co values for the sample.This review concluded because the elevated s/co results were reproducible, the issue was likely attributable to a non-specific interaction unique to the sample.Therefore, a return sample was not requested for the complaint investigation.A retained kit of alinity s hiv ag/ab combo reagent, lot number 12175be00 was tested in a clinical specificity setup using a human negative population panel and additional replicates of negative control.The results were in the typical range and no false reactive results were obtained.Manufacturing documentation for the reagent lot was reviewed and did not identify any issues associated with false reactive results.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the available information and this investigation, no systemic issue or deficiency of the alinity s hiv ag/ab combo assay was identified.

• Brand Name: ALINITY S HIV AG/AB COMBO
• Type of Device: HIV-1 AND HIV-2 ANTIBODIES
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10116521
• MDR Text Key: 228394326
• Report Number: 3002809144-2020-00431
• 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: 11/20/2020
• Device Catalogue Number: 06P01-55
• Device Lot Number: 12175BE00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/18/2020
• Initial Date FDA Received: 06/03/2020
• Supplement Dates Manufacturer Received: 06/18/2020
• 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).