MAUDE Adverse Event Report: ABBOTT GMBH ALINITY I ANTI-HBC

Catalog Number 07P87-22

Device Problem False Negative Result (1225)

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

Event Date 01/06/2020

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.This report is being filed on an international product, list number 7p87 that has a similar product distributed in the us, list number 7p84.

Event Description

The customer observed a (b)(6) alinity i anti-hbc ii result for 1 patient with a history of being (b)(6).The following data was provided: (b)(6) 2020 sid (b)(6) initial result = (b)(6), repeat = (b)(6).Additional laboratory data supplied for the same sample.All data was reviewed, and no additional discrepant results were generated.No impact to patient management was reported.

Manufacturer Narrative

A review of tickets was performed for reagent lot number 04203be00.The ticket search determined that there is normal complaint activity for the likely cause lot with regards to false non-reactive results.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 04203be00 was tested in a sensitivity setup.The sensitivity panel showed normal performance and no false non-reactive results were obtained.Additionally, two commercially available seroconversion panels were tested with reagent lot 04203be00 was.The results were compared to the architect anti-hbc ii results provided by the panel manufacturer.Reagent lot 04203be00 was detected the same bleeds as reactive.Based on these data it was shown that the sensitivity performance is not adversely affected.A review of the manufacturing documentation did not identify any issues associated with the customer's complaint.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect anti-hbc ii assay, lot 04203be00.

• Brand Name: ALINITY I ANTI-HBC
• Type of Device: ANTI-HBC
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9655816
• MDR Text Key: 217670454
• Report Number: 3002809144-2020-00075
• 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: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2020
• Device Catalogue Number: 07P87-22
• Device Lot Number: 04203BE00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/06/2020
• 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)(6).; SERIAL (B)(6).