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)
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.There is no further patient information provided by the customer.
Event or Problem Description
The customer reported (b)(6) architect hbsag results on one patient.The results provided were: (b)(6); confirmatory testing (b)(6) = confirmed (b)(6).The customer questioned the results because the (b)(6) result = (b)(6) indicating immunity to (b)(6), so they retested the sample = (b)(6)).There was no reported impact to patient management.
Additional Manufacturer Narrative
A review of the attachments confirms the customer's observation.A review of tickets searches determined normal complaint activity for lot 92151fn00 with this being the only complaint received to date.A review for trends did not identify any for lot 92151fn00.Specificity testing was performed with a retained kit of lot 92151fn00 and all specifications were met indicating the lot is performing acceptably.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.It is possible that discrepant results were due to sample integrity/handling issues at the time of testing.For accurate results, serum and plasma specimens should be free of fibrin, red blood cells, and other particulate matter.Customers should ensure that complete clot formation in serum specimens has taken place prior to centrifugation.If the specimen is centrifuged before a complete clot forms, the presence of fibrin may cause erroneous results.The customer agreed that fibrin in the sample possibly contributed to the discrepant results and checks have been put in place to inspect for fibrin and ultracentrifuge any suspect samples.Based on the investigation no product deficiency was identified for the architect hbsag confirmatory, lot 92151fn00.

• 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: 8336437
• Report Number: 3008344661-2019-00014
• Device Sequence Number: 14042766
• Product Code: LOM
• UDI-Device Identifier: 00380740007799
• UDI-Public: 00380740007799
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2019
• Device Catalogue Number: 04P54-25
• Device Lot Number: 92151FN00
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/24/2019
• Supplement Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 02/13/2019
• Supplement Report FDA Received Date: 04/30/2019
• 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, LN 03M74-02; ARCHITECT I2000SR ANALYZER, LN 03M74-02,; SERIAL # (B)(4); SERIAL # (B)(4)