MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT HBSAG QUALITATIVE II

Catalog Number 02G22-30

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/23/2019

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product list 2g22, that has a similar us product distributed in the us, list 4p53.Patient identifier, does not contain enough spaces, full id is (b)(6).An evaluation is in process.A followup report will be submitted when the evaluation is complete.

Event Description

The account generated (b)(6) on a donor ((b)(6) year old non-caucasian male) id (b)(6) on (b)(6) 2019.Additionally, the donor tested (b)(6), murex (b)(6), biorad (b)(6).No impact to patient/donor was reported.No additional specific patient information provided.

Manufacturer Narrative

Complaint ticket searches identified normal complaint activity for lot 94053fn00.Complaint trending report review determined no adverse trend for the issue for the product.The 2 return patient sample tubes were tested using an in-house retained kit of lot 94053fn00 and the hbsag q ii results (0.83 and 0.72 s/co) matched the nature of the customer complaint (nonreactive result).Clinical sensitivity testing was performed using an in-house retained kit of lot 94053fn00.All specifications were met indicating the lot is preforming acceptably.A review of the product quality history for lot 94053fn00 using search of the corrective and preventive actions system did not identify any issues associated with the customer observation.A review of product labeling concluded that the issue is sufficiently addressed.Using worldwide data a review of customer field data was performed for the assay which showed no atypical performance for the lot.No product deficiency was identified.

Manufacturer Narrative

Update to section lot number and section an evaluation is in process.A followup report will be submitted when the evaluation is complete.

Event Description

Additional information provided that the account stated the hepatitis b positive donor obtained a new sample which generated pcr positive results but architect method negative (0.97 s/co) and reactive (1.05 s/co) results.

• Brand Name: ARCHITECT HBSAG QUALITATIVE II
• Type of Device: HBSAG
• Manufacturer (Section D): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• MDR Report Key: 8764660
• MDR Text Key: 194157426
• Report Number: 3008344661-2019-00080
• Device Sequence Number: 1
• Product Code: KSJ
• 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,Followup
• Report Date: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2019
• Device Catalogue Number: 02G22-30
• Device Lot Number: 94053FN00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT LIST 03M74-02; ARCHITECT LIST 03M74-02; ARCHITECT LIST 03M74-02; SERIAL (B)(4); SERIAL (B)(4); SERIAL (B)(4)
• Patient Age: 38 YR