MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I HBSAG QUALITATIVE 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 08/09/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.Patient identifier sid's: (b)(6).This report is being filed on an international product, list number 8p11-22 that has a similar product distributed in the us, list number 8p11-21.

Event Description

The customer reported a false positive alinity i (b)(6) qualitative ii confirmatory result on one patient.Results provided: on (b)(6) 2020 sid (b)(6) (heparin sample) = (b)(6) = 2.06 / 1.78 / 0.91 s/co, (b)(6) = 10.05 / 10.774 / 10.929 / 10.929 s/co, sid (b)(6) (serum sample) (b)(6) confirmatory = negative, roche (b)(6) = negative, (b)(6) = 12.656 s/co; sid (b)(6) (different serum sample) (b)(6) = 12.02 s/co, (b)(6) confirmatory = positive; (b)(6) dna tagman negative.No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for potential false confirmed hbsag qualitative ii results included a search for similar complaints, trending data, labeling, and device history records.A review of the result data provided by the customer was also performed.In-house testing of reagent lot 10241fn00 was completed.Return testing was not completed as returns were not available.Lot and trending review determined no trend for the issue for the product and no elevated complaint activity for the lot.Device history record review on lot 10241fn00 did not show any potential non-conformances, or deviations.Labeling was reviewed and found to adequately address the issue under review.In house testing of controls which mimic patient samples was completed using retained samples of the complaint lot.All specifications were met indicating that the lot is performing acceptably.Based on the investigation, no systemic issue or deficiency of the alinity i hbsag qualitative ii confirmatory assay, lot number 10241fn00 was identified.

Event Description

The customer reported a false positive alinity i hbsag qualitative ii confirmatory result on one patient.Results provided: (b)(6) 2020 sid (b)(6) (heparin sample) = hbsag = 2.06 / 1.78 / 0.91 s/co, hbeag = 10.05 / 10.774 / 10.929 / 10.929 s/co, sid (b)(6) (serum sample) hbsag confirmatory = negative, roche hbsag = negative, hbeag = 12.656 s/co; sid (b)(6) (different serum sample) hbeag = 12.02 s/co, hbsag confirmatory = positive; hbv dna tagman negative.No impact to patient management was reported.

• Brand Name: ALINITY I HBSAG QUALITATIVE II CONFIRMATORY
• Type of Device: HBSAG CONFIRMATORY
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; diagnostics division; sligo NA ; EI NA
• MDR Report Key: 10487961
• MDR Text Key: 233926257
• Report Number: 3008344661-2020-00066
• 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: 10/28/2020

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: 11/13/2020
• Device Catalogue Number: 08P11-22
• Device Lot Number: 10241FN00
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/17/2020
• Initial Date FDA Received: 09/03/2020
• Supplement Dates Manufacturer Received: 10/28/2020
• Supplement Dates FDA Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY I PROCESSING MODULE LIST 03R65-01; ALNTY I PROCESSING MODU, 03R65-01, (B)(6) ; SERIAL (B)(6)