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)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no further information provided by the customer for donors.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed (b)(6) alinity s anti-hcv results on multiple donor specimens which confirmed negative by confirmatory testing.The results provided were: (b)(6).The alinity s processing module not in test of record before (b)(6) 2021.Those data provided (b)(6) 2020 through (b)(6) 2020 for validation on alinity s processing module.There was no reported impact to patient management.
Additional Manufacturer Narrative
This submission being send for additional information provided on 25aug2021; section d10: new concomitant product: was updated to include alnty s processing modu, 06p16-01; serial number: (b)(6).
Additional Manufacturer Narrative
The complaint evaluation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, field data history of alinity s anti-hcv reagent, ln 6p04-60, lot number 22195be00.The ticket search determined that there is normal complaint activity for the likely cause lot.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.The customer data review for alinity s anti-hcv reagent, lot number 22195be00 was performed.The analysis included initial reactive rates (irr), repeat reactive rates (rrr) and specificity (assuming zero prevalence) at innovative blood resources (ibr), us whole blood (wb) peer sites and across all us customer sites and us whole blood (wb) peer sites.The specificity and reactive rate performance of lot 22195be00 at ibr is comparable to the performance at peer sites and within product requirements.Further, the overall irr, rrr and specificity of lots 22195be00 across all us customer sites are within product requirements and accordant to the performance of all lots of the same assay evaluated in the comparison (irr: 0.056 to 0.251%; rrr: 0.054 to 0.251%; specificity: 99.749 to 99.946%).A review of the manufacturing documentation did not identify any issues associated with the customer¿s observation.There was no issue with reagent performance identified.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the alinity s anti-hcv reagent, lot number 22195be00.
Additional Manufacturer Narrative
Section b5 was updated to remove the statement ¿the alinity s processing module not in test of record before (b)(6) 2021.Those data provided (b)(6) 2020 through (b)(6) 2020 for validation on alinity s processing module.¿ and add a clarification to indicate that the customer only provided a summary of results and did not provide any individual patient results.Section g1 contact information was updated to reflect the current contact (b)(6).
Event or Problem Description
The customer observed false repeat reactive alinity s anti-hcv results on multiple donor specimens which confirmed negative by confirmatory testing.The customer provided the following summary of repeat reactive and confirmatory results across several months/reagent lots.No individual patient results were provided.(b)(6) 2021 repeat reactive=26 / confirmatory testing negative= 20; (b)(6) 2021 repeat reactive=34/ confirmatory testing negative = 30; (b)(6) 2021 repeat reactive=28 / confirmatory testing negative = 16; (b)(6) 2021 repeat reactive=27 / confirmatory testing negative = 17; (b)(6) 2021 repeat reactive=31 / confirmatory testing negative = 21; (b)(6) 2021 repeat reactive=24 / confirmatory testing negative = 17.There was no reported impact to patient management.

• 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: siobhan wright ; lisnamuck; post market surveillance; longford, IL N39 E-932 ; 2246682940
• MDR Report Key: 12354408
• Report Number: 3002809144-2021-00508
• Device Sequence Number: 6753837
• Product Code: QHM
• UDI-Device Identifier: 00380740117191
• UDI-Public: 00380740117191
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: 200
• 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,Followup,Followup
• Report Date (Section B): 01/11/2022

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: 10/08/2021
• Device Catalogue Number: 06P04-60
• Device Lot Number: 22195BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 08/25/2021; 11/03/2021; 12/28/2021
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 09/21/2021; 11/11/2021; 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2021
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY S SYSTEM, 06P16-01, AS1235; ALNTY S SYSTEM, 06P16-01, AS1235; ALNTY S SYSTEM, 06P16-01, AS1235; ALNTY S SYSTEM, 06P16-01, AS1235, AS1248, AS1249; AS1248 AND AS1249; AS1248 AND AS1249
• Patient Sex: Unknown