MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT HBSAG QUALITATIVE CONFIRMATORY; HBSAG CONFIRMATORY

Catalog Number	04P54-25
Medical Device Problem Code	Low Test Results (2458)
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.
Event or Problem Description
The customer stated that the architect analyzer generated (b)(6) confirmatory (b)(6) results on one patient.The results provided were: sid (b)(6) on (b)(6) 2017 initial = (b)(6) / re-centrifuged and retested = (b)(6).(b)(6) confirmatory testing = (b)(6) / -3% neut = not confirmed.The customer repeated the confirmatory testing = (b)(6) / 79% neut = confirmed (b)(6).There was no reported impact to patient management.There was no additional patient information provided.
Additional Manufacturer Narrative
Evaluation of the customer issue included a review of the complaint text, a review for similar complaints, a review of labeling, manufacturing records, and sensitivity panel testing.No patient samples were available for return.The customer observed that one patient generated repeatedly (b)(6) results when tested with the hbsag qualitative assay list 4p53, which was not confirmed when using architect hbsag qualitative confirmatory assay, 4p54-25, lot 66215fn00.A review of complaints determined that there is no unusual activity and no trends for lot 66215fn00.Sensitivity testing of panels which mimic patient samples, was performed using a retained kit of lot 66215fn00, and 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.Per labeling if the architect hbsag qualitative confirmatory results are inconsistent with clinical evidence, additional testing is suggested to confirm the result.Also, the architect system operations manual provides adequate instructions for causes of erratic results and troubleshooting steps to resolve the issue.A malfunction was identified as the device failed to meet performance specifications or otherwise perform as intended at the customer site.Based on all available information and this investigation, the assay performed as intended and no product deficiency was identified.Serial # was 66215fn00, should be blank; lot # was blank, should be 66215fn00.

• Brand Name: ARCHITECT HBSAG QUALITATIVE CONFIRMATORY
• Common Device Name: HBSAG CONFIRMATORY
• Manufacturer (Section D): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• MDR Report Key: 6417392
• Report Number: 3008344661-2017-00021
• Device Sequence Number: 16305517
• Product Code: LOM
• UDI-Device Identifier: 00380740007799
• UDI-Public: (01)00380740007799(17)170327(10)66215FN00
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P110029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2017

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: 03/27/2017
• Device Catalogue Number: 04P54-25
• Device Lot Number: 66215FN00
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/23/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2017
• Supplement Report FDA Received Date: 04/03/2017
• 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 I2000SR ANALYZER, LIST # 03M74-98,; SERIAL # (B)(4)