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 03/20/2023

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section a1 - patient identifier complete entry = sample id 1, sample id 2, and sample id 3 all available patient information was included.Additional patient details are not available.Section e1 - phone complete entry = (b)(6).This report is being filed on an international product, list number 08p06-74, that has a similar product distributed in the us, list number 08p05.

Event Description

The customer observed false nonreactive alinity i anti-hcv results for several patients.The following data was provided (<1.00 s/co is nonreactive, >/=1.00 s/co is reactive): sample id 1 initial result was 0.42, repeat was 0.47 s/co.The sample was tested with a maccura assay, and the results were 36.715 and 36.444, which are reactive.Also was tested with a roche assay and the result was 6.52, which is reactive.Sample id 2 initial result was 0.54, repeat was 0.67 s/co.The sample was tested with a maccura assay, and the results were 6.576 and 6.879, which are reactive.Also was tested with a roche assay and the result was 9.5, which is reactive.Sample id 3 initial result was 0.25, repeat was 0.22 s/co.The sample was tested with a maccura assay, and the result was 7.25, which is reactive.There was no impact to patient management reported.

Event Description

The customer observed false nonreactive alinity i anti-hcv results for several patients.The following data was provided (<1.00 s/co is nonreactive, >/=1.00 s/co is reactive): sample id 1 initial result was 0.42, repeat was 0.47 s/co.The sample was tested with a maccura assay, and the results were 36.715 and 36.444, which are reactive.Also was tested with a roche assay and the result was 6.52, which is reactive.Sample id 2 initial result was 0.54, repeat was 0.67 s/co.The sample was tested with a maccura assay, and the results were 6.576 and 6.879, which are reactive.Also was tested with a roche assay and the result was 9.5, which is reactive.Sample id 3 initial result was 0.25, repeat was 0.22 s/co.The sample was tested with a maccura assay, and the result was 7.25, which is reactive.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for false nonreactive 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 testing of the complaint lot number.Trending review determined no related trend for the issue for the product.Return testing was not completed, as returns were not available.Sensitivity testing was performed using an in-house retained kit of lot 44535be01, stored at the recommended storage condition.All specifications were met indicating that the lot is performing acceptably.In addition, the clinical sensitivity of the lot was evaluated by testing two commercially available seroconversion panels (zeptometrix hcv 9047 and hcv 9045).The seroconversion panel results were compared to historical architect anti-hcv test results provided by zeptometrix, since architect anti-hcv and alinity i anti-hcv assays are equivalent.The lot detected the same bleeds as reactive for the seroconversion panels.Based on these data it was shown that the sensitivity performance of the complaint lot is not adversely affected.Device history record review did not identify any non-conformances or deviations with the likely cause lot and complaint issue.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency of alinity i anti-hcv reagent, lot number 44535be01, 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: 16674844
• MDR Text Key: 313026546
• Report Number: 3002809144-2023-00180
• 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: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2023
• Device Catalogue Number: 08P06-74
• Device Lot Number: 44535BE01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2022
• 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).