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

Catalog Number	04P54-25
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/15/2017
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 stated that they received a (b)(6) result on a labor and delivery patient.The results from (b)(6) 2017 =1.43s/co / sample repeated = 1.36s/co (>/=1.00s/co = (b)(6)) / confirmatory testing performed = c2 1.30 / neutralization = 102.94% (c2 >/=0.70 and % neut >/=50% = confirmed (b)(6)).Physician questioned the results and requested a new sample, drawn (b)(6) 2017 = 0.75s/co (<1.00s/co = (b)(6)).The customer retested the (b)(6) 2017 sample after re-centrifuging and generated 1.36 / 1.41 / repeated confirmatory = c2 1.30 / 100.619% neut.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, trend reports, complaint searches, product labeling, manufacturing records, and specificity testing.A patient sample was returned, but there was an inadequate volume to perform testing.A review of ticket searches determined no unusual complaint activity.Historical performance of list 4p53 was evaluated using world wide data from abbott link.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 67292fn00 is within the established control limits and no unusual reagent lot performance was identified.No adverse trend was identified for the customer's issue.Testing of a serum based panel was performed using a retained kit of list 4p54, lot 67302fn00, which mimics a patient sample.All specifications were met indicating that lot 67302fn00 is performing acceptably.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of labeling was performed - the assays do not have 100% specificity and if the architect hbsag qualitative /architect hbsag qualitative confirmatory results are inconsistent with clinical evidence, additional testing is suggested to confirm the result.Based on the information within the complaint record a malfunction was identified, the device failed to meet performance specifications or otherwise perform as intended at the customer site.There was no product deficiency identified.

• 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: 6304398
• Report Number: 3008344661-2017-00009
• Device Sequence Number: 16342997
• Product Code: LOM
• UDI-Device Identifier: 00380740007799
• UDI-Public: (01)00380740007799(17)170429(10)67302FN00
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/31/2017

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: 04/29/2017
• Device Catalogue Number: 04P54-25
• Device Lot Number: 67302FN00
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/16/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2017
• Supplement Report FDA Received Date: 03/31/2017
• 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)
• Patient Age: 36 YR