MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT ANTI-HBC II

Catalog Number 08L44-25

Device Problem False Negative Result (1225)

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

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product, list number 8l44 that has a similar product distributed in the us, list number 6l22.Patient information: (b)(6) female patient diagnosed with malignant lymphoma.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed (b)(6) architect anti- hbc ii result on (b)(6) year old female patient diagnosed with malignant lymphoma.The results were provided: (b)(6).Previous history from 2012 (b)(6).There was no reported impact to patient management.

Manufacturer Narrative

A review of tickets was performed for reagent lot number 07400be00.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 retained reagent kit of lot number 07400be00 was tested in a sensitivity setup, including additional replicates of a sensitivity panel.Results of this setup did not implicate that the performance of the lot was negatively impacted.No false non-reactive results were obtained.A manufacturing documentation for the reagent lot was reviewed and did not identify any issues.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.Based on the investigation no product deficiency was identified for the architect anti-hbc ii , lot number 07400be00.

• Brand Name: ARCHITECT ANTI-HBC II
• Type of Device: ANTI-HBC
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9793697
• MDR Text Key: 193065067
• Report Number: 3002809144-2020-00169
• 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: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2020
• Device Catalogue Number: 08L44-25
• Device Lot Number: 07400BE00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/12/2020
• Initial Date FDA Received: 03/05/2020
• Supplement Dates Manufacturer Received: 03/30/2020
• Supplement Dates FDA Received: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER; ARCHITECT I2000SR ANALYZER; LN 03M74-01, SERIAL (B)(4).; LN 03M74-01, SERIAL (B)(4).
• Patient Age: 72 YR