MAUDE Adverse Event Report: ABBOTT GMBH ALINITY S HIV AG/AB COMBO REAGENT KIT; 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 05/07/2020

Event Type  malfunction  

Manufacturer Narrative

This issue was previously reported under mdr number 1628664-2020-00115 under a different suspect device.Patient identifier is sid (b)(6).This report is being filed on an international product, alinity s hiv 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.There was no additional patient information provided by the customer.

Event Description

The customer reported (b)(6) alinity s (b)(6) results on one donor.The results provided were: on (b)(6) 2020 sid (b)(6) initial = (b)(6) / second result = (b)(6).There was no reported impact to donor/patient management.

Manufacturer Narrative

During the site visit, the abbott ambassador cleaned the turret, replaced the optics roller and cleaned/lubricated the reaction vessel lifter.A review of tickets determined that there is normal complaint activity for alinity s hiv ag/ab combo, lot 12175be00.Return testing was not completed as returns were not available.Clinical specificity was evaluated by testing a human negative population panel with a retained kit of lot 12175be00.No false reactive results were obtained, indicating acceptable product performance.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.The abbott technical support team reviewed the complaint information and s/co values that the customer provided.Inconsistent results such as these in close proximity can be caused by particulate matter or a lipid layer on the sample.The instructions for use indicates that "specimens containing visible particulate matter may give erroneous or inconsistent test results." based on the investigation no product deficiency was identified for the alinity s hiv ag/ab combo, lot 12175be00.

• Brand Name: ALINITY S HIV AG/AB COMBO REAGENT KIT
• 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: 10171212
• MDR Text Key: 197096875
• Report Number: 3002809144-2020-00486
• 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: 06/26/2020

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: 05/29/2020
• Initial Date FDA Received: 06/18/2020
• Supplement Dates Manufacturer Received: 06/26/2020
• Supplement Dates FDA Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY S SYSTEM, LN 06P16-01.; ALINITY S SYSTEM, LN 06P16-01.; SERIAL # (B)(6).; SERIAL # (B)(6).