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

Catalog Number 06P04-60

Device Problem False Positive Result (1227)

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

Event Date 02/13/2024

Event Type  malfunction  

Event Description

Hold for cs the customer reported false repeat reactive alinity s anti-hcv results for 4 donors who have a history of nonreactive anti-hcv results.Between (b)(6) 2024 to (b)(6) 2024 while running on the alinity s system the following data was provided by the customer: (b)(6) : initial result = 1.65 s/co; repeat results = 1.64 and 2.57 s/co (reagent lot 53019be00).(b)(6) : initial result = 2.42 s/co; repeat results = 2.52 and 2.56 s/co (reagent lot 53019be00).(b)(6) : initial result = 2.85 s/co; repeat results = 2.83 and 2.68 s/co (reagent lot 53019be00).(b)(6) : initial result = 1.42 s/co; repeat results = 1.48 and 1.50 s/co (reagent lot 53019be00).All 4 donors were tested with nat testing and supplemental eia testing and generated nonreactive results for all 4 donors.These donor units were rejected and not released due to the anti-hcv reactive results generated.There was no impact to patient management reported.

Manufacturer Narrative

A1 - patient identifier: (b)(6) (4 separate donors).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 reported false repeat reactive alinity s anti-hcv results for 4 donors who have a history of nonreactive anti-hcv results.Between (b)(6) 2024 to (b)(6) 2024 while running on the alinity s system the following data was provided by the customer: (b)(6) : initial result = 1.65 s/co; repeat results = 1.64 and 2.57 s/co (reagent lot 53019be00).(b)(6): initial result = 2.42 s/co; repeat results = 2.52 and 2.56 s/co (reagent lot 53019be00).(b)(6): initial result = 2.85 s/co; repeat results = 2.83 and 2.68 s/co (reagent lot 53019be00).(b)(6): initial result = 1.42 s/co; repeat results = 1.48 and 1.50 s/co (reagent lot 53019be00).All 4 donors were tested with nat testing and supplemental eia testing and generated nonreactive results for all 4 donors.These donor units were rejected and not released due to the anti-hcv reactive results generated.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.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The evaluation of complaint data for the product and reagent lot 53019be00 did not identify an increase in complaint activity for the complaint issue.A review of ticket tracking and trending did not identify any related trends for the product for the issue.The review of the device history record did not identify any non-conformances, potential non-conformances, and deviations associated with the reagent lot 53019be00 and complaint issue.Labeling was reviewed and adequately addresses the issue under review.A review of field data was reviewed for alinity s anti-hcv was performed.Overall reactive rates of ln 6p04-60, lot 53019be00 at f inova nokes blood donor (usa), applicable peer sites and across a whole blood and plasma screening monitoring group were collected and assessed.Across the whole blood and plasma screening monitoring group, the customer, and their peer sites the performance of lot 53019be00 is within product requirements.The specificity performance of these lots at the customer site is comparable to peers.Based on the investigation, alinity s anti-hcv reagent lot 53019be00 is performing as intended, no systemic issue or product deficiency was identified.

• 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: 18764178
• MDR Text Key: 336506128
• Report Number: 3002809144-2024-00044
• Device Sequence Number: 1
• Product Code: QHM
• UDI-Device Identifier: 00380740117191
• UDI-Public: 00380740117191
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BL 125677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2024

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: 05/16/2024
• Device Catalogue Number: 06P04-60
• Device Lot Number: 53019BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 02/22/2024
• Supplement Dates Manufacturer Received: 03/13/2024
• Supplement Dates FDA Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2023
• 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)