MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I ANTI-HBS

Catalog Number 07P89-74

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Manufacturer Narrative

All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.This report is being filed on an international product, alinity anti-hbs list 7p89 that has a similar product distributed in the us, list number 7p88.

Event Description

The customer obtained a false elevated alinity i anti-hbs result, for a (b)(6) year old male patient with a history of (b)(6) infection.The sample generated a result of >1000 on the alinity and non-reactive on the autobio assay.The customer further indicated the sample was tested on an architect at an alternate lab and generated the same result as the alinity.No impact to patient management was reported.

Manufacturer Narrative

No customer returns were available for investigation.The alinity i anti-hbs reagent lot 01009fn00 was evaluated using an in-house retained kit.All specifications were met indicating the lot is performing acceptably.Complaint searches determined normal complaint activity for reagent lot 01009fn00.The complaint trending report review determined that there is no related trends associated with the issue.Manufacturing documentation associated with the reagent lot did not identify any issues.Labeling was reviewed and found to be adequate.Based on all available information no systemic issue or deficiency was identified.

• Brand Name: ALINITY I ANTI-HBS
• Type of Device: ANTI-HBS
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; diagnostics division; sligo NA ; EI NA
• MDR Report Key: 9668206
• MDR Text Key: 220246909
• Report Number: 3008344661-2020-00011
• 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: 03/24/2020

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: 05/18/2020
• Device Catalogue Number: 07P89-74
• Device Lot Number: 01009FN00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/13/2020
• Initial Date FDA Received: 02/04/2020
• Supplement Dates Manufacturer Received: 03/19/2020
• Supplement Dates FDA Received: 03/24/2020
• 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) ; SN (B)(6)
• Patient Age: 64 YR