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 02/23/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Was this device serviced by a third party.No see for further information regarding patient identifiers.An evaluation is in process.A follow up report will be submitted when the evaluation is complete.

Event Description

The customer generated false repeat reactive alinity s (b)(6) results for several organ transplant donors in comparison to another method grifols panther nat.The following information was provided: alinity s (b)(6) sid (b)(6) initial result (b)(6), repeat (b)(6).Nat testing not detected.Supplemental testing with another method (eia) (b)(6).This sample was taken premortem.Sid (b)(6) initial result (b)(6).Nat testing not detected.Supplemental testing with another method (eia) (b)(6).This sample was taken postmortem.Sid (b)(6) initial result (b)(6).Nat testing not detected.Supplemental testing with another method (eia) (b)(6).This sample was taken premortem.Sid (b)(6) initial result (b)(6), nat testing not detected.Supplemental testing with another method (eia) (b)(6).This sample was taken premortem.Sid (b)(6) initial result (b)(6) this sample was taken premortem.Sid (b)(6) initial result (b)(6) this sample was taken premortem.Sid (b)(6) initial result (b)(6)) this sample was taken postmortem.No impact to patient management was reported.No organ transplants were delayed as a result of this event.

Manufacturer Narrative

This follow up is being submitted to include d8 and h6 information previously submitted using the h10 section in their respective fields.Additionally a device evaluation was completed: a review of tickets was performed for the reagent lot.The ticket search determined that there is normal complaint activity.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.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the device was identified.Additionally, d9 - device available for eval has been corrected to no.

• 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
• MDR Report Key: 11579709
• MDR Text Key: 249018872
• Report Number: 3002809144-2021-00205
• Device Sequence Number: 1
• Product Code: MZO
• UDI-Device Identifier: 00380740117191
• UDI-Public: 00380740117191
• Combination Product (y/n): N
• PMA/PMN Number: QHM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/21/2021
• Device Catalogue Number: 06P04-60
• Device Lot Number: 19534BE00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY S SYSTEM, 06P16-01, AS1290.; ALNTY S SYSTEM, 06P16-01, AS1290.