MAUDE Adverse Event Report: ABBOTT GMBH ALINITY S ANTI-HCV REAGENT KIT; HEPATITIS C VIRUS ENCODED ANTIGENS (RECOMBINANT C100-3, HCR43)

Catalog Number 06P04-55

Device Problem False Positive Result (1227)

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

Event Date 11/21/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 6p04-55 that has a similar product distributed in the us, list number 6p04-60.

Event Description

The customer observed false reactive alinity s (b)(6) results on one donor specimen sid (b)(6) ran after known reactive donor specimen sid (b)(6).The results provided were: different specimen type results provided as below for that donor.(b)(6).There was no reported impact to patient management.

Manufacturer Narrative

The ticket search determined that there is normal complaint activity for the likely cause lot.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.The alinity s anti-hcv test results for the serum sample (repeat reactive) align with the reference laboratory test results (positive for anti-hcv and hcv nat).Further, a review of the results data by engineering demonstrated that there is no evidence of potential sample contamination attributable to the instrument.A review of the product labeling concluded that the issue is sufficiently addressed.Based on our investigation, we have determined that there is no a systemic issue and/or product deficiency with alinity s anti-hcv lot number 16534be00.

• Brand Name: ALINITY S ANTI-HCV REAGENT KIT
• Type of Device: HEPATITIS C VIRUS ENCODED ANTIGENS (RECOMBINANT C100-3, HCR43)
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 11131844
• MDR Text Key: 255330665
• Report Number: 3002809144-2021-00012
• 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: 01/25/2021

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: 02/05/2021
• Device Catalogue Number: 06P04-55
• Device Lot Number: 16534BE00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2020
• Initial Date FDA Received: 01/07/2021
• Supplement Dates Manufacturer Received: 01/22/2021
• Supplement Dates FDA Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY S SYSTEM, 06P16-01, (B)(4); ALNTY S SYSTEM, 06P16-01, (B)(4)