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

Catalog Number 06C37-74

Device Problem False Negative Result (1225)

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

Event Date 01/01/2024

Event Type  malfunction  

Event Description

A literature article by li h, yang s, cao d, wang q, zhang s, zhou y, liu d, yang r, cui l and zhu z (2023), ¿a new double-antigen sandwich test based on the light-initiated chemiluminescent assay for detecting anti-hepatitis c virus antibodies with high sensitivity and specificity¿, frontiers in cellular and infection microbiology 13:1222778, documented false nonreactive architect anti-hcv results generated on the architect i2000sr processing module for 6 patient samples.The samples were tested with other methods and the anti-hcv results were confirmed positive.The following data was provided in the article: architect anti-hcv result = 0.27 s/co (nonreactive) lica 500 system result = 3.07 s/co (reactive) roche cobas result = 14.33 s/co (reactive) riba 3.0 result = positive (bands on riba = core1, core2, ns3, ns4) hcv rna = negative anti-hcv confirmatory result = positive architect anti-hcv result = 0.17 s/co (nonreactive) lica 500 system result = 1.70 s/co (reactive) roche cobas result = 12.19 s/co (reactive) riba 3.0 result = positive (bands on riba = core1, core2, ns3, helicase) hcv rna = negative anti-hcv confirmatory result = positive architect anti-hcv result = 0.18 s/co (nonreactive) lica 500 system result = 1.38 s/co (reactive) roche cobas result = 11.23 s/co (reactive) riba 3.0 result = positive (bands on riba = core1, core2, ns3, ns5) hcv rna = negative anti-hcv confirmatory result = positive architect anti-hcv result = 0.12 s/co (nonreactive) lica 500 system result = 1.20 s/co (reactive) roche cobas result = 6.42 s/co (reactive) riba 3.0 result = positive (bands on riba = core1, core2, ns3) hcv rna = negative anti-hcv confirmatory result = positive architect anti-hcv result = 0.94 s/co (nonreactive) lica 500 system result = 54.73 s/co (reactive) roche cobas result = 59.66 s/co (reactive) riba 3.0 result = indeterminate (bands on riba = ns3, ns4) hcv rna = negative anti-hcv confirmatory result = positive architect anti-hcv result = 0.05 s/co (nonreactive) lica 500 system result = 12.11 s/co (reactive) roche cobas result = 26.17 s/co (reactive) riba 3.0 result = indeterminate (bands on riba = ns3, ns4) hcv rna = 857 iu/ml anti-hcv confirmatory result = positive there was no impact to patient management reported.

Manufacturer Narrative

This report is being filed on an international product, architect anti-hcv, list number 06c37-74, that has a similar product distributed in the us, list number 01l79.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

A literature article by li h, yang s, cao d, wang q, zhang s, zhou y, liu d, yang r, cui l and zhu z (2023), ¿a new double-antigen sandwich test based on the light-initiated chemiluminescent assay for detecting anti-hepatitis c virus antibodies with high sensitivity and specificity¿, frontiers in cellular and infection microbiology 13:1222778, documented false nonreactive architect anti-hcv results generated on the architect i2000sr processing module for 6 patient samples.The samples were tested with other methods and the anti-hcv results were confirmed positive.The following data was provided in the article: architect anti-hcv result = 0.27 s/co (nonreactive).Lica 500 system result = 3.07 s/co (reactive).Roche cobas result = 14.33 s/co (reactive).Riba 3.0 result = positive (bands on riba = core1, core2, ns3, ns4).Hcv rna = negative.Anti-hcv confirmatory result = positive.Architect anti-hcv result = 0.17 s/co (nonreactive).Lica 500 system result = 1.70 s/co (reactive).Roche cobas result = 12.19 s/co (reactive).Riba 3.0 result = positive (bands on riba = core1, core2, ns3, helicase).Hcv rna = negative.Anti-hcv confirmatory result = positive.Architect anti-hcv result = 0.18 s/co (nonreactive).Lica 500 system result = 1.38 s/co (reactive).Roche cobas result = 11.23 s/co (reactive).Riba 3.0 result = positive (bands on riba = core1, core2, ns3, ns5).Hcv rna = negative.Anti-hcv confirmatory result = positive.Architect anti-hcv result = 0.12 s/co (nonreactive).Lica 500 system result = 1.20 s/co (reactive).Roche cobas result = 6.42 s/co (reactive).Riba 3.0 result = positive (bands on riba = core1, core2, ns3).Hcv rna = negative.Anti-hcv confirmatory result = positive.Architect anti-hcv result = 0.94 s/co (nonreactive).Lica 500 system result = 54.73 s/co (reactive).Roche cobas result = 59.66 s/co (reactive).Riba 3.0 result = indeterminate (bands on riba = ns3, ns4).Hcv rna = negative.Anti-hcv confirmatory result = positive.Architect anti-hcv result = 0.05 s/co (nonreactive).Lica 500 system result = 12.11 s/co (reactive).Roche cobas result = 26.17 s/co (reactive).Riba 3.0 result = indeterminate (bands on riba = ns3, ns4).Hcv rna = 857 iu/ml.Anti-hcv confirmatory result = positive.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation false nonreactive architect anti-hcv results included a review of data and information from the article ¿a new double-antigen sandwich test based on the light-initiated chemiluminescent assay for detecting anti-hepatitis c virus antibodies with high sensitivity and specificity¿, ticket trending review, device history record review, and labeling review.Return testing was not completed as returns were not available.The data and information provided in the article were reviewed and support the complaint issue.A ticket search by lot could not be performed as the likely cause lot is unknown.A review of the complaint trending report did not identify any trends for the issue for the product.A review of the device history record did not identify any non-conformances or deviations with the likely cause list number and the complaint issue.A review of labeling was performed and found to sufficiently address the customer's issue.Based on this investigation, no systemic issue or deficiency was identified with the architect anti-hcv reagent, lot number unknown.

• 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18525436
• MDR Text Key: 333342065
• Report Number: 3002809144-2024-00012
• 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,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06C37-74
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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)(6) ; ARC I2000SR INST, 03M74-02, (B)(6)