MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT ANTI-HBS

Catalog Number 07C18-29

Device Problem High Test Results (2457)

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

Event Date 07/30/2019

Event Type  malfunction  

Manufacturer Narrative

All available patient information has been included.No additional patient details are available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported false reactive anti-hbs and anti-hbc results when processing on the architect i2000sr.The following data was provided: anti-hbs: initial result was 34.53 and retests were 36.68 and 30.17 miu/ml.Additional information testing was provided for the customer and included anti-hbc: initial result was 8.17 and retest was 8.22 s/co.The patient's previous results (b)(6) 2019) for this patient were: anti-hbs 3.9 miu/ml and anti-hbc 9.61 s/co.The customer uses less than 10 miu/ml for anti-hbs.No impact to patient management was reported.

Manufacturer Narrative

An investigation was performed for the customer issue and included a review of the complaint text, a search for similar complaints, a review of trending data, a review of performance data, a review of product quality history, and a review of product labeling.The ticket searches determined normal complaint activity for the likely cause lot.The complaint trending report review did not identify any trends.Field data was reviewed and determined that the patient median result for the likely cause product lot 01347fn00 is comparable with all other lots in the field and within established baselines which confirms no systemic issue for the lot.A review of the product quality history for the lot number using search did not identify issues associated with the customer observation.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation a product deficiency was not identified.

• Brand Name: ARCHITECT ANTI-HBS
• Type of Device: ANTI-HBS
• Manufacturer (Section D): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• MDR Report Key: 8916721
• MDR Text Key: 155086063
• Report Number: 3008344661-2019-00107
• 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: 11/25/2019

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: 05/14/2020
• Device Catalogue Number: 07C18-29
• Device Lot Number: 01347FN00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/31/2019
• Initial Date FDA Received: 08/21/2019
• Supplement Dates Manufacturer Received: 11/21/2019
• Supplement Dates FDA Received: 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR, LIST 03M74-02; SERIAL (B)(4); ARCHITECT I2000SR, LIST 03M74-02; SERIAL (B)(4)