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

Catalog Number 06C37-78

Device Problem False Negative Result (1225)

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

Event Date 10/31/2022

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product, architect anti-hcv, list number 6c37-78, that has a similar product distributed in the us, list number 01l79.All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed false nonreactive architect anti-hcv results for a patient with a history of positive anti-hcv result.The result was not reported out of the lab because the positive control was out of customer's range, however, it was still within the package insert range.The customer replaced the reagent with the same lot number and positive control came back in range.The patient was retested with the new reagent and the result was consistent with the patient history.The following data was provided (<1.00 s/co is nonreactive, >/=1.00 s/co is reactive): initial result = 0.98 s/co, repeat result after recalibration = 0.81 s/co, repeat result with new bottle of reagent = 1.23 s/co, patient¿s historical result = 1.13 s/co no impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for false nonreactive architect anti-hcv results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Additionally, in-house sensitivity testing was completed.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 40346be01 and the complaint issue.In-house sensitivity testing of a retained reagent kit of the lot 40346be00 was performed (reagent lot 40346be00 and 40346be01 contain the same bulk material).All specifications were met, and no false non-reactive results were obtained, showing that the lots generate the expected results.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.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.Labeling was reviewed and sufficiently addresses the customer's issue.Based on our investigation, no systemic issue or deficiency with the architect anti-hcv reagent for lot 40346be01 was identified.

• Brand Name: ARCHITECT 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: 15864811
• MDR Text Key: 307702806
• Report Number: 3002809144-2022-00411
• 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: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2023
• Device Catalogue Number: 06C37-78
• Device Lot Number: 40346BE01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, (B)(4); ARC I2000SR INST, 03M74-02, (B)(4)