MAUDE Adverse Event Report: ABBOTT GERMANY ALINITY S ANTI-HCV

Catalog Number 06P04-55

Device Problems Incorrect Or Inadequate Test Results (2456); Low Test Results (2458)

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

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 6p04 that has a similar product distributed in the us, list number 1l79.Mdr number 1415939-2018-00093 has been submitted to document the prism hcv method results and all further information for the prism reagents will be documented under that mdr number.

Event Description

The customer observed (b)(6) antibodies to (b)(6) results while using alinity s anti-hcv reagents during a comparison study between the alinity s system and the roche cobas e801 system.The following data was provided.(b)(6).Roche cobas e801 method was repeatedly (b)(6).Other methods were (b)(6), including prism hcv (b)(6) and hcv nat by pool pcr, confirmatory testing hcv id-nat.Inno-lia hcv score (fujirebio method) showed a weak band.A follow up sample from the same donor three weeks later was (b)(6) using prism anti-hcv method and id-nat method, however was (b)(6) with 2 bands using fujirebio blot.Mikrogen recomline hcv blot was (b)(6) for both specimens (core 1, helicase, and ns4).No impact to patient or donor management was reported.

Manufacturer Narrative

Evaluation of the customer issue included a complaint text review, a search for similar complaints, device history review, and labeling review.The product was not returned.No adverse trend was identified for the customer issue.Device history review did not identify any issues that may have caused the customer issue.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics evaluation, no systemic issue was identified and no product deficiency was found.

• Brand Name: ALINITY S ANTI-HCV
• Type of Device: ANTI-HCV
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 7617481
• MDR Text Key: 112576021
• Report Number: 3002809144-2018-00065
• Device Sequence Number: 1
• Product Code: MZO
• 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: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2018
• Device Catalogue Number: 06P04-55
• Device Lot Number: 82086LI00
• Date Manufacturer Received: 08/03/2018
• Patient Sequence Number: 1
• Treatment: ALINITY S ANALYZER; ALINITY S ANALYZER; LIST NUMBER 06P16-01; LN 06P16-01 SN (B)(4).; SERIAL NUMBER (B)(4).