MAUDE Adverse Event Report: ABBOTT GMBH ALINITY S ANTI-HBC REAGENT KIT; HEPATITIS B VIRUS CORE ANTIGEN (E COLI, RECOMBINANT)

Catalog Number	06P06-60
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Was this device serviced by a third party? no.See report regarding patient information.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer generated (b)(6) alinity s anti-hbc results for several organ transplant donors in comparison to another method (grifols' panther nat).The following information was provided: alinity s anti-hbc: sid (b)(6): initial result: (b)(6); supplemental testing with another method (eia) (b)(6).This sample was taken premortem.Sid (b)(6): initial result: (b)(6); supplemental testing with another method (eia) (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.
Additional 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-HBC REAGENT KIT
• Common Device Name: HEPATITIS B VIRUS CORE ANTIGEN (E COLI, RECOMBINANT)
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 11579723
• Report Number: 3002809144-2021-00204
• Device Sequence Number: 14352166
• Product Code: QHM
• UDI-Device Identifier: 00380740117207
• UDI-Public: 00380740117207
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2021

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: 03/26/2021
• Device Catalogue Number: 06P06-60
• Device Lot Number: 15152BE00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/03/2021
• Supplement Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 03/27/2021
• Supplement Report FDA Received Date: 05/17/2021
• 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, AS1290; ALNTY S SYSTEM, 06P16-01, AS1290