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

Catalog Number	01L82-35
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/11/2017
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.
Event or Problem Description
The customer observed (b)(6) architect ausab results for two patients.Sid (b)(6): initial (b)(6) reran in duplicate (b)(6) (grayzone).Sid (b)(6): initial (b)(6) reran in duplicate (b)(6).No adverse impact to patient management was reported.
Additional Manufacturer Narrative
Historical complaint data was reviewed to determine whether other customers have experienced the complaint issue.This review showed no adverse trend for the product over the last 12 months and normal complaint activity for the product lot.No patient sample was available for return; therefore clinical specificity testing of calibrator a replicates, which is a plasma based sample, was performed using in-house retained kits stored at the recommended storage condition.All specifications were met indicating that the lot is performing acceptably.A review of the manufacturing documentation did not identify any issues associated with the customer observation.A malfunction was identified.Based on the information within the complaint record, the device failed to meet performance specifications or otherwise perform as intended at the customer site.Based on all available information, no product deficiency was identified.
Additional Manufacturer Narrative
The customer provided clarification on april 25, 2017 regarding the sample ids and test results for the two patients.This new information has been entered.
Event or Problem Description
(b)(6).

• 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: 6450997
• Report Number: 3008344661-2017-00026
• Device Sequence Number: 18947958
• Product Code: LOM
• UDI-Device Identifier: 00380740001520
• UDI-Public: 00380740001520
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Medical Technologist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/03/2017

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: 09/22/2017
• Device Catalogue Number: 01L82-35
• Device Lot Number: 65149FN00
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/11/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/31/2017
• Supplement Report FDA Received Date: 04/24/2017; 05/03/2017
• 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 I1000SR ANALYZER; LIST 01L86-01, SERIAL (B)(4)