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	09/28/2021
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.Patient identifier sids:(b)(6).
Event or Problem Description
The customer reported (b)(6) alinity s anti-hcv results on two donors.Results provided: (b)(6) 2021 sid(b)(6), nat = (b)(6).(b)(6) 2021, sid (b)(6) = (b)(6).Nat = (b)(6).No impact to donor management was reported.
Additional Manufacturer Narrative
The evaluation of complaint data for the product and likely cause alinity s anti-hcv reagent lot 26209be00 identified normal complaint activity.No customer returns were available for evaluation.Inhouse testing determined that the specificity performance is not negatively impacted.A technical evaluation of differences between the alinity s anti-hcv and abbott prism hcv was performed.While both assays utilize chemiluminescence, the assays differ in their principle and composition.Due to differences in platform, methodology and assay design, different results between the assays and platforms cannot be excluded.The device met performance specifications at the customer site as based on the total number of samples tested with lot 26209be00 and the number of reactive samples at the customer site, the specificity (assuming a zero prevalence of hcv infection for the tested samples) is calculated to be 99.93%, which is within the product requirement for specificity of the alinity s anti-hcv assay.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.The performance of the likely cause lot was investigated by completing a review for non-conformances, potential non-conformances and deviations related to the likely cause lot.This review did not identify any non-conformances, potential non-conformances or deviations.A review of labeling concluded that the issue is sufficiently addressed.No systemic issue or product deficiency was identified with alinity s anti-hcv reagent lot 26209be00.

• 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: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 12726876
• Report Number: 3002809144-2021-00623
• Device Sequence Number: 4446726
• Product Code: QHM
• UDI-Device Identifier: 00380740117191
• UDI-Public: 00380740117191
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 11/16/2021

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: 02/11/2022
• Device Catalogue Number: 06P04-60
• Device Lot Number: 26209BE00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2021
• Supplement Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 11/01/2021
• Supplement Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2021
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY S SYSTEM, 06P16-01, (B)(4); ALNTY S SYSTEM, 06P16-01, (B)(4)
• Patient Sex: Unknown