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

Catalog Number 06C37-27

Device Problem False Negative Result (1225)

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

Event Date 12/02/2021

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A followup report will be submitted when the evaluation is complete.

Event Description

The account observed (b)(6) architect anti-hcv on a patient who previously tested hcv (b)(6).The patient generated architect anti-hcv (b)(6) ((b)(6)) result but previously was anti-hcv (b)(6) ((b)(6) in 2018, (b)(6) in 2016).The patient is (b)(6) male with elevated afp, pivka and a cancer diagnosis and multiple medications.Patient race/ethnicity not provided.No impact to patient management was reported.

Manufacturer Narrative

Section g1.Contact name, address, email, phone, fax updated.The ticket search by lot indicates that the reagent lot performs as expected for this product.The ticket trending review of complaint data for the likely cause list number does not identify any adverse trend.Labeling review concludes that the issue is adequately addressed.A review in the corrective and preventive actions system does not identify any related non-conformances or deviations associated with the likely cause lot and complaint issue.In-house testing of a retained reagent kit of the complaint lot was performed, showing that the lot generates the expected results.All specifications were met and no false non-reactive results were obtained, indicating that the sensitivity performance is not negatively impacted.In addition, the clinical sensitivity of the lot was evaluated by testing two commercially available seroconversion panels.The seroconversion panel results were compared to historical architect anti-hcv test results provided by manufacturer.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.No product deficiency was identified.Section g1.Contact name, address, email, phone, fax updated.

• 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, IL N39 E-932 ; EI N39 E932 ; 2246682940
• MDR Report Key: 13065936
• MDR Text Key: 283180838
• Report Number: 3002809144-2021-00717
• Device Sequence Number: 1
• Product Code: MZO
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2022
• Device Catalogue Number: 06C37-27
• Device Lot Number: 30030BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2K PROC MOD, 03M74-01, (B)(6); ARC I2K PROC MOD, 03M74-01, (B)(6)
• Patient Age: 95 YR
• Patient Sex: Male