MAUDE Adverse Event Report: ABBOTT GMBH ALINITY I ANTI-HCV REAGENT KIT; ASSAY, ENZYME LINKED IMMUNOSORBENT, HEPATITIS C VIRUS

Catalog Number 08P06-74

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2022

Event Type  malfunction  

Event Description

The customer reported false negative alinity i anti-hcv results for 2 patients.The 2 patient samples tested positive with roche and autobio platform methods while the 2 patients tested negative using the alinity i anti-hcv assay.There was no impact to patient management reported.

Manufacturer Narrative

All available patient information is included.Additional patient details are not available.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 8p06 that has a similar product distributed in the us, list number 8p05.

Manufacturer Narrative

The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and in house testing of a retained reagent kit.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Ticket search by lot indicates the reagent lot performs as expected.Ticket trending review did not identify any trends.Device history record review did not identify any non-conformances or deviations with the complaint lot number.In-house testing of a retained reagent kit of the complaint lot was performed.All controls met specifications and no false non-reactive results were obtained, indicating that the sensitivity performance is not negatively impacted.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or deficiency with the alinity i anti-hcv reagent lot 41397be01 was identified.

• Brand Name: ALINITY I ANTI-HCV REAGENT KIT
• Type of Device: ASSAY, ENZYME LINKED IMMUNOSORBENT, HEPATITIS C VIRUS
• 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 15874188
• MDR Text Key: 307700919
• Report Number: 3002809144-2022-00414
• Device Sequence Number: 1
• Product Code: MZO
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N/A
• 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,Followup
• Report Date: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2023
• Device Catalogue Number: 08P06-74
• Device Lot Number: 41397BE01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, (B)(6) ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6)