MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT AUSAB; ANTI-HBS

Catalog Number	01L82-37
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Patient identifier: complete entry is (b)(6).No further patient information was provided.
Event or Problem Description
The customer reported erratic and falsely elevated architect ausab results.Sample id (b)(6) which generated multiple negative results (6.97, 3.65, 3.55 and 3.98 miu/ml) and one reactive result of 69.19 miu/ml).No specific patient information was provided.No adverse impact to patient management was reported.
Additional Manufacturer Narrative
Review of complaint activity did not identify any adverse or non-statistical trends for the architect ausab assay.Normal complaint activity was identified for llikely cause lot 87205fn00.Historical testing which was performed for between assay reagent cross-contamination for the ausab assay was reviewed.The susceptibility study was performed to evaluated architect ausab susceptibility to reagent contamination from other assays including hbsag.The study met the run evaluation criteria.Therefore, it was determined that bias caused by potential reagent cross-contamination will unlikely impact assay results.A second cross contamination study was reviewed which used the ausab and hbsag assays.All acceptance criteria were met and the customers observation was not repeated in house.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.Additionally, labeling was reviewed and sufficiently addresses the customer' issue.No systemic issue or deficiency of the architect ausab assay was identified.Also refer to manufacturer report number 1628664-2018-01964 for the device evaluation of the architect i2000sr analyzer.

• Brand Name: ARCHITECT AUSAB
• Common Device Name: ANTI-HBS
• Manufacturer (Section D): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• MDR Report Key: 7929600
• Report Number: 3008344661-2018-00082
• Device Sequence Number: 13789820
• Product Code: LOM
• UDI-Device Identifier: 00380740115371
• UDI-Public: 00380740115371
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P050051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/09/2019
• Device Catalogue Number: 01L82-37
• Device Lot Number: 87205FN00
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/22/2018
• Supplement Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 12/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT I2000SR ANALYZER,; ARCHITECT I2000SR ANALYZER,; LIST 03M74-02, SERIAL (B)(4) ; LIST 03M74-02, SERIAL (B)(4) ; ARCHITECT I2000SR ANALYZER,; LIST 03M74-02, SERIAL (B)(4)