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 03/01/2023

Event Type  malfunction  

Event Description

The customer observed false nonreactive alinity i anti-hcv results for multiple samples when compared to another method since the beginning of march.The following data was provided (units of measure is s/co): sid 64: alinity result = 0.43, roche result = 1.68.Sid 62: alinity result = 0.91, roche result = 20.15.Sid 76: alinity result = 0.14, roche result = 5.66.Sid 59: alinity result = 0.07, roche result = 63.24.Sid 60: alinity result = 0.31, roche result = 11.99.Sid 70: alinity result = 0.04, roche result = 1.56.Sid 60: alinity result = 0.41, roche result = 5.12.Sid 30: alinity result = 0.02, roche result = 1.26.Sid 68: alinity result = 0.13, roche result = 1.090.Sid 37: alinity result = 0.04, roche result = 0.954.Sid 69: alinity result = 0.05, roche result = 2.86.Sid 62: alinity result = 0.42, roche result = 31.65.Sid 68: alinity result = 0.96, roche result = 7.91.Sid 65: alinity result = 0.05, roche result = 1.08.Sid 64: alinity result = 0.53, roche result = 10.11.Sid 49: alinity result = 0.08, roche result = 1.13.Sid 63: alinity result = 0.40, roche result = 13.41.Sid 3: alinity result = 0.04, roche result = 10.41.No impact to patient management was reported.

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 8p06 has a similar product distributed in the us, list number 8p05.

Event Description

The customer observed false nonreactive alinity i anti-hcv results for multiple samples when compared to another method since the beginning of march.The following data was provided (units of measure is s/co): sid (b)(6): alinity result = 0.43, roche result = 1.68 sid (b)(6): alinity result = 0.91, roche result = 20.15 sid (b)(6): alinity result = 0.14, roche result = 5.66 sid (b)(6): alinity result = 0.07, roche result = 63.24 sid (b)(6): alinity result = 0.31, roche result = 11.99 sid (b)(6): alinity result = 0.04, roche result = 1.56 sid (b)(6): alinity result = 0.41, roche result = 5.12 sid (b)(6): alinity result = 0.02, roche result = 1.26 sid (b)(6): alinity result = 0.13, roche result = 1.090 sid (b)(6): alinity result = 0.04, roche result = 0.954 sid (b)(6): alinity result = 0.05, roche result = 2.86 sid (b)(6): alinity result = 0.42, roche result = 31.65 sid (b)(6): alinity result = 0.96, roche result = 7.91 sid (b)(6): alinity result = 0.05, roche result = 1.08 sid (b)(6): alinity result = 0.53, roche result = 10.11 sid (b)(6): alinity result = 0.08, roche result = 1.13 sid (b)(6): alinity result = 0.40, roche result = 13.41 sid (b)(6): alinity result = 0.04, roche result = 10.41 no impact to patient management was reported.

Manufacturer Narrative

After further review on 22jun2023, section d4 lot # was updated from 45437be00 to 45437be01 and catalog # was updated from 08p06-77 to 08p06-74.Additional concomitant products were added.These updates were inadvertently omitted with the supplemental report.

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 in-house testing.Return testing was not completed as returns were not available.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lot 45437be01 and the complaint issue.In-house sensitivity testing was completed with lot number 45437be00 (lot number 45437be00 contains the same bulk material as 45437be01).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 (zeptometrix hcv).The seroconversion panel results were compared to architect anti-hcv test results provided by zeptometrix (since architect anti-hcv and alinity i anti-hcv assays are equivalent).Lot 45437be00 detected the same bleeds as reactive with comparable s/co values for the seroconversion panels.Labeling was reviewed and found to be adequate.Based on our investigation, no systemic issue or deficiency with the alinity i anti-hcv reagent for lot 45437be01 was identified.

Event Description

The customer observed false nonreactive alinity i anti-hcv results for multiple samples when compared to another method since the beginning of march.The following data was provided (units of measure is s/co): sid (b)(6): alinity result = 0.43, roche result = 1.68 sid (b)(6): alinity result = 0.91, roche result = 20.15 sid (b)(6): alinity result = 0.14, roche result = 5.66 sid (b)(6): alinity result = 0.07, roche result = 63.24 sid (b)(6): alinity result = 0.31, roche result = 11.99 sid (b)(6): alinity result = 0.04, roche result = 1.56 sid (b)(6): alinity result = 0.41, roche result = 5.12 sid (b)(6): alinity result = 0.02, roche result = 1.26 sid (b)(6): alinity result = 0.13, roche result = 1.090 sid (b)(6): alinity result = 0.04, roche result = 0.954 sid (b)(6): alinity result = 0.05, roche result = 2.86 sid (b)(6): alinity result = 0.42, roche result = 31.65 sid (b)(6): alinity result = 0.96, roche result = 7.91 sid (b)(6): alinity result = 0.05, roche result = 1.08 sid (b)(6): alinity result = 0.53, roche result = 10.11 sid (b)(6): alinity result = 0.08, roche result = 1.13 sid (b)(6): alinity result = 0.40, roche result = 13.41 sid (b)(6): alinity result = 0.04, roche result = 10.41 no impact to patient management was reported.

• 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: 16794990
• MDR Text Key: 313817188
• Report Number: 3002809144-2023-00198
• Device Sequence Number: 1
• Product Code: MZO
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 07/06/2023

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: 07/27/2023
• Device Catalogue Number: 08P06-74
• Device Lot Number: 45437BE01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2023
• Initial Date FDA Received: 04/24/2023
• Supplement Dates Manufacturer Received: 06/29/2023; 06/29/2023
• Supplement Dates FDA Received: 07/06/2023; 07/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2022
• 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).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).