MAUDE Adverse Event Report: ABBOTT GMBH ALINITY S ANTI-HCV REAGENT KIT; HEPATITIS C VIRUS ENCODED ANTIGENS (RECOMBINANT C100-3, HCR43)

Catalog Number 06P04-55

Device Problem False Positive Result (1227)

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

Event Date 10/05/2023

Event Type  malfunction  

Manufacturer Narrative

A1 - patient identifier: (b)(6).All available patient information was included.Additional patient details are not available.This report is being filed on an international product, list number 06p04-55 that has a similar product distributed in the us, list number 06p04-60.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported false reactive alinity s anti-hcv results for multiple samples while running on the alinity s system.The following data was provided: sample id (b)(6): initial = 1.757 / serum repeat = 1.769 / plasma repeat = 1.343.Sample id (b)(6): initial = 1.314 / serum repeat = 1.439 / plasma repeat = 1.076.Sample id (b)(6): initial = 11.412 / serum repeat = 10.46 / plasma repeat = 11.240.Sample id (b)(6): initial = 1.693 / serum repeat = 1.772 / plasma repeat = 1.472.Sample id (b)(6): initial = 2.516 / serum repeat = 2.104 / plasma repeat = 2.347.Sample id (b)(6): initial = 1.486 / serum repeat = 1.693 / plasma repeat = 1.246.Sample id (b)(6): initial = 1.072 / serum repeat = 1.039 / plasma repeat = 0.926.Sample id (b)(6): initial = 1.235 / serum repeat = 1.218 / plasma repeat = 0.909.Sample id (b)(6): initial = 1.054 / serum repeat = 1.116 / plasma repeat = 0.882.Sample id (b)(6): initial = 4.894 / serum repeat = 4.671 / plasma repeat = 4.310.Sample id (b)(6): initial = 0.981 / serum repeat = 1.052 / plasma repeat = 0.714.The customer stated results with values between 0.900 and 0.999 s/co are considered in the grayzone and the blood components were discarded due the grayzone reactivity.Nat testing was performed and all samples generated negative results.There was no impact to patient management reported.

Event Description

The customer reported false reactive alinity s anti-hcv results for multiple samples while running on the alinity s system.The following data was provided: sample id (b)(6) : initial = 1.757 / serum repeat = 1.769 / plasma repeat = 1.343.Sample id (b)(6) : initial = 1.314 / serum repeat = 1.439 / plasma repeat = 1.076.Sample id (b)(6) : initial = 11.412 / serum repeat = 10.46 / plasma repeat = 11.240.Sample id (b)(6) : initial = 1.693 / serum repeat = 1.772 / plasma repeat = 1.472.Sample id (b)(6) : initial = 2.516 / serum repeat = 2.104 / plasma repeat = 2.347.Sample id (b)(6) : initial = 1.486 / serum repeat = 1.693 / plasma repeat = 1.246.Sample id (b)(6) : initial = 1.072 / serum repeat = 1.039 / plasma repeat = 0.926.Sample id (b)(6) : initial = 1.235 / serum repeat = 1.218 / plasma repeat = 0.909.Sample id (b)(6) : initial = 1.054 / serum repeat = 1.116 / plasma repeat = 0.882.Sample id (b)(6) : initial = 4.894 / serum repeat = 4.671 / plasma repeat = 4.310.Sample id (b)(6) : initial = 0.981 / serum repeat = 1.052 / plasma repeat = 0.714.The customer stated results with values between 0.900 and 0.999 s/co are considered in the grayzone and the blood components were discarded due the grayzone reactivity.Nat testing was performed and all samples generated negative results.There was no impact to patient management reported.Update: on 31oct2023, customer provided updated nat results stating that sample (b)(6) is the only one with positive nat results which correlate to the serological testing provided.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation 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 field data review.Return testing was not completed as returns were not available.Evaluation of complaint data for the product and reagent lot 47447be00 did not identify an increase in complaint activity for the complaint issue.A review of tracking and trending did not identify any related trends for the product for the issue.A review of the device history records did not identify any non-conformances, potential non-conformances and deviations related to the reagent lot 47447be00 and complaint issue.A review of customer field data was performed to assess field performance, initial reactive rates, repeat reactive rates and specificity (assuming 0 prevalence) were calculated per lot number per month.The performance within each month and subgrouping is within product specifications.Overall reactive rates of lot number 47447be00 across higuera escalante & cia.Ltda.(colombia), applicable peer sites and across a whole blood and plasma group were collected and assessed.Across the whole blood and plasma group, the customer and their peer sites, the performance for the lot is within product requirements.Labeling was reviewed and concluded that the issue is sufficiently addressed.Based on the investigation, alinity s anti-hcv reagent lot 47447be00 is performing as intended, no systemic issue or product deficiency was identified.

Manufacturer Narrative

B5 - describe event or problem - update: on 31oct2023, customer provided updated nat results stating that sample 466052 was the only one with positive nat results which correlate to the serological testing provided.

Event Description

Update: on 31oct2023, customer provided updated nat results stating that sample 466052 is the only one with positive nat results which correlate to the serological testing provided.There was no impact to patient management reported.

• Brand Name: ALINITY S ANTI-HCV REAGENT KIT
• Type of Device: HEPATITIS C VIRUS ENCODED ANTIGENS (RECOMBINANT C100-3, HCR43)
• 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: 18029201
• MDR Text Key: 326847546
• Report Number: 3002809144-2023-00452
• Device Sequence Number: 1
• Product Code: QHM
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 12/04/2023

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: 12/08/2023
• Device Catalogue Number: 06P04-55
• Device Lot Number: 47447BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2023
• Initial Date FDA Received: 10/30/2023
• Supplement Dates Manufacturer Received: 10/31/2023; 11/27/2023
• Supplement Dates FDA Received: 11/27/2023; 12/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY S SYSTEM, 06P16-01, (B)(6) ; ALNTY S SYSTEM, 06P16-01, (B)(6) ; ALNTY S SYSTEM, 06P16-01, (B)(6)