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
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed false reactive alinity s anti-hcv results when compared to another method for one donor sample.This donor sample previously tested repeat reactive on alinity s hcv (6p04) and was a stored sample.The sample was pulled and used for the validation studies for a different assay (alinity s hcv ii (4w56).The following results were provided: alinity s anti-hcv (b)(6) 2024 initial result 2.85 s/co, repeated 2.48 and 2.33 s/co (repeat reactive), orho hcv repeat reactive, nat negative, alinity s anti-hcv ii (b)(6) 2024 initial result 0.01 s/co, repeated 0.01 and 0.01 s/co (negative).The sample was tested again for investigation purpose and the following data was provided: alinity s anti-hcv (investigation using serum (b)(6) 2024) initial result 2.17 s/co, repeated 1.39 and 1.28 s/co, alinity s anti-hcv (investigation using plasma (b)(6) 2024) initial result 2.50 s/co, repeated 2.63 and 2.67 s/co.No impact to patient management was reported.
Additional Manufacturer Narrative
Data and information provided by the customer were reviewed and support the complaint issue.Evaluation of complaint data for the product lots did not identify an increase in complaint activity for the complaint issue.Return testing was not completed as returns were not available.Ticket trending review did not identify any trends.Device history review did not identify any non-conformances or deviations with the complaint lot.A review of field data for alinity s anti-hcv was performed.Overall reactive rates of alinity s anti-hcv, ln 6p04-60, lot 62165be00 across bloodworks northwest, 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 62165be00 is within product requirements and comparable to other lots analyzed in the comparison.Whole blood and plasma screening monitoring group lot 62165be00: irr: 0.057 %, rrr: 0.055 %, irr - rrr 0.001 %, specificity: 99.945 %.Peer sites lot 62165be00: irr: 0.123 %, rrr: 0.120 %, irr - rrr 0.003 %, specificity: 99.880 %.Bloodworks northwest lot 62165be00: irr: 0.174 %, rrr: 0.164 %, irr - rrr 0.011 %, specificity: 99.836 %.Based on this investigation, the alinity s anti-hcv reagent, ln 6p04-60, lot 62165be00 are performing as expected.A review of labeling concluded that the issue is sufficiently addressed.Based on the information provided, a systemic issue and/or product deficiency was not identified.Based on the information within the complaint record, the device met performance specifications at the customer site.
Event or Problem Description
The customer observed false reactive alinity s anti-hcv results when compared to another method for one donor sample.This donor sample previously tested repeat reactive on alinity s hcv (6p04) and was a stored sample.The sample was pulled and used for the validation studies for a different assay (alinity s hcv ii (4w56).The following results were provided: alinity s anti-hcv ((b)(6) 2024) initial result 2.85 s/co, repeated 2.48 and 2.33 s/co (repeat reactive), orho hcv repeat reactive, nat negative, alinity s anti-hcv ii ((b)(6) 2024) initial result 0.01 s/co, repeated 0.01 and 0.01 s/co (negative).The sample was tested again for investigation purpose and the following data was provided: alinity s anti-hcv (investigation using serum (b)(6) 2024) initial result 2.17 s/co, repeated 1.39 and 1.28 s/co, alinity s anti-hcv (investigation using plasma (b)(6) 2024) initial result 2.50 s/co, repeated 2.63 and 2.67 s/co.No impact to patient management was reported.

• Brand Name: ALINITY S ANTI-HCV REAGENT KIT
• Common Device Name: 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: 20440816
• Report Number: 3002809144-2024-00293
• Device Sequence Number: 8267032
• Product Code: QHM
• UDI-Device Identifier: 00380740117191
• UDI-Public: (01)00380740117191(17)250214(10)62165BE00
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: BL 125677
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/14/2025
• Device Catalogue Number: 06P04-60
• Device Lot Number: 62165BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/24/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY S SYSTEM, 06P16-01, (B)(6); ALNTY S SYSTEM, 06P16-01, (B)(6)
• Patient Sex: Unknown