MAUDE Adverse Event Report: ABBOTT IRELAND ALINITY I HBSAG QUALITIATIVE II CONFIRMATORY; HBSAG CONFIRMATORY

Catalog Number 08P11-22

Device Problem False Positive Result (1227)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/09/2019

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: (b)(6).Patient information: no further patient information was provided by the customer.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed a false reactive alinity i hbsag qualitative ii confirmatory result for 1 patient.The following data was provided: (b)(6) 2019 sid (b)(6) initial result = 1.524 s/co (reactive), repeats = 1.682 s/co (reactive), 1.672 s/co (reactive), 1.585 s/co (reactive).Neutralization confirmatory = 104.026% (reactive) sample is negative by another method.No impact to patient management was reported.

Manufacturer Narrative

A review of tickets was performed for reagent lot number 01535fn00.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.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 alinity i hbsag qualitative ii confirmatory assay, lot 01535fn00 was identified.

• Brand Name: ALINITY I HBSAG QUALITIATIVE II CONFIRMATORY
• Type of Device: HBSAG CONFIRMATORY
• Manufacturer (Section D): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• MDR Report Key: 9262458
• MDR Text Key: 219773738
• Report Number: 3008344661-2019-00129
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/18/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2019
• Device Catalogue Number: 08P11-22
• Device Lot Number: 01535FN00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/17/2019
• Initial Date FDA Received: 10/31/2019
• Supplement Dates Manufacturer Received: 12/18/2019
• Supplement Dates FDA Received: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY I PROCESSING MODULE, LIST 03R65-01; ALINITY I PROCESSING MODULE, LIST 03R65-01; SERIAL (B)(4); SERIAL (B)(4)