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

Catalog Number 08P06-23

Device Problem False Negative Result (1225)

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

Event Date 11/30/2022

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Completed information for patient identification: sid (b)(6).This report is being filed on an international product, list number 08p06 that has a similar product distributed in the us, list number 08p05.All available patient information was included.Additional patient details are not available.

Event Description

The customer observed false negative alinity i anti-hcv results for a patient with chronic kidney disease on dialysis.The customer stated the patient tested before dialysis every time.The alinity i gave non-reactive results with 2 samples, but the backup machine gave reactive for both samples.Example result provided: (b)(6) 2022 sid (b)(6) initial result = 0.2 s/co, and the ortho clinical diagnostics backup instrument result = 3.0 s/co.The patient has a history of being anti-hcv positive for 2 years.No impact to patient management was reported.

Event Description

The customer observed false negative alinity i anti-hcv results for a patient with chronic kidney disease.The customer stated the patient tested before dialysis every time.The alinity i gave non-reactive results with 2 samples, but the backup machine gave reactive for both samples.Example result provided: (b)(6) 2022 sid (b)(6) initial result = 0.2 s/co, and the ortho clinical diagnostics backup instrument result = 3.0 s/co.The patient has a history of being anti-hcv positive for 2 years and is a dialysis patient.No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for falsely negative alinity i anti-hcv results 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.Return testing was not completed as returns were not available.A review of tracking and trending did not identify any trends for the complaint issue.Labeling was reviewed and found to adequately address the issue.Device history record review on lot 40319be00 did not show any potential non-conformances, deviations, or non-conformances associated with the complaint issue.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.Testing included two commercially available seroconversion panels.Lot 40319be00 detected the same bleeds as reactive with comparable s/co values for the seroconversion panels.Based on the investigation, no systemic issue or deficiency of the alinity i anti-hcv assay for lot number 40319be00 was identified.All available patient information was included.Additional patient details are not available.

• 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: 16013605
• MDR Text Key: 308528343
• Report Number: 3002809144-2022-00448
• Device Sequence Number: 1
• Product Code: MZO
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/21/2023
• Device Catalogue Number: 08P06-23
• Device Lot Number: 40319BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2022
• 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, AI02656; ALNTY I PROCESSING MODU, 03R65-01, AI02656