MAUDE Adverse Event Report: ABBOTT GMBH ALINITY I ANTI-HCV REAGENT KIT; ASSAY, ENZYME LINKED IMMUNOSORBENT, HEPATITIS C VIRUS

Catalog Number 08P06-74

Device Problem False Negative Result (1225)

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

Event Date 11/01/2022

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed false nonreactive alinity i anti-hcv results on one patient.The results provided were: on (b)(6) 2022 initial= 0.55 s/co (< 1.00 s/co=nonreactive)) /repeated= 0.45 s/co, 0.89 s/co and 0.99 s/co /repeated after re-centrifuged=nonreactive (no actual results provided) /repeated with new lot of reagent=2.48 s/co (> or = 1.00 s/co=reactive) /previous history in (b)(6) =2.36 s/co there was no reported impact to patient management.

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 and field data of alinity i anti-hcv reagent lot 40373be01.The evaluation of complaint data for the product and likely cause alinity i anti-hcv reagent lot 40373be01 identified as expected.Trending review determined no adverse trend for the issue for the product.The ticket trending review of at least 12 months complaint data for the likely cause list number does not identify any adverse or non-statistical trend.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.The return specimen was tested with a retained kit of alinity i anti-hcv reagent lot number 40373be01.Reactive results (2.33 s/co/ 2.00 s/co/ 2.11 s/co) were obtained.Further mikorgen recomline hcv igg testing was performed.Two weak bands (ns3 and helicase) with intensity below the cut off were identified.The interpretation is negative.Historical performance of the alinity i anti-hcv reagents in the field using data gathered via abbottlink from customers worldwide.The number of standard deviations to the cut-off for the negative populations and the median values, determined the likely cause lots are within their established limits.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 i anti-hcv reagent lot number 40373be01.

• Brand Name: ALINITY I ANTI-HCV REAGENT KIT
• Type of Device: ASSAY, ENZYME LINKED IMMUNOSORBENT, HEPATITIS C VIRUS
• 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 N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 15781030
• MDR Text Key: 307601181
• Report Number: 3002809144-2022-00395
• Device Sequence Number: 1
• Product Code: MZO
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N/A
• 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
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2023
• Device Catalogue Number: 08P06-74
• Device Lot Number: 40373BE01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODULE, 03R65-01, (B)(6) ; ALNTY I PROCESSING MODULE, 03R65-01, (B)(6)