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	07/03/2018
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.Refer to mdr number 344661-2018-00069 for the report documenting use of architect hbsag qual reagent.An evaluation is in process.
Event or Problem Description
The customer observed multiple (b)(6) results while using architect hbsag qualitative confirmatory reagents.The following data was provided.Sid (b)(6) (tested (b)(6) 2018) initial (b)(6) ((b)(6)), repeat (b)(6) ((b)(6)).Confirmatory testing was (b)(6).(b)(6) method was (b)(6).Sid (b)(6) (tested (b)(6) 2018) initial (b)(6) ((b)(6)), repeat (b)(6) ((b)(6)).Confirmatory testing was (b)(6).The customer stated the same specimen was repeated an hour and a half later and (b)(6) results were observed for both methods, however the specific values were not provided.(b)(6) method was (b)(6).No impact to patient management was reported.
Additional Manufacturer Narrative
Additional information was received regarding the patient specimen confirmatory result disposition and included that neither patient specimen was confirmed hbsag reactive (nonreactive for hbsag).Neither specimen result using the suspect product was considered discrepant.Based on this information, this complaint is no longer a reportable event.
Additional Manufacturer Narrative
Describe event or problem was updated with new information for the patients and test date for sid (b)(6) year was updated as 2018 from 2028.Suspect medical device 4.Catalog number and lot number was changed to ln 04p54-25 ln 85274fn00 from 04p54-25 ln unknown.Concomitant medical products update to ln 04p53-25 ln 85264fn00 from 04p53 ln unknown.Device evaluated by mfr: an evaluation is in process.
Event or Problem Description
On october 18, 2018, additional information was provided.Sid (b)(6) 2.58 s/co 0.85% confirmatory neutralization.Sid (b)(6) 2.18 s/co, 0.23% % confirmatory neutralization, additional repeat was nonreactive (0.25 s/co).Per the product package insert, %neutralization values less than 15% are considered invalid.Corrected test date, sid (b)(6) was tested on (b)(6) 2018.

• 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: 7791591
• Report Number: 3008344661-2018-00070
• Device Sequence Number: 16731197
• Product Code: LOM
• UDI-Device Identifier: 00380740007799
• UDI-Public: 00380740007799
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/09/2018

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 Catalogue Number: 04P54-25
• Device Lot Number: 85274FN00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/26/2018
• Supplement Date Received by Manufacturer: 10/18/2018; 10/24/2018
• Initial Report FDA Received Date: 08/16/2018
• Supplement Report FDA Received Date: 10/19/2018; 11/09/2018
• 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 LN 03M74-02; ARCHITECT I2000SR LN 03M74-02; ARCHITECT I2000SR LN 03M74-02; LN 04P53 LN UNKNOWN; LN 04P53-25 LN 85264FN00; LN 04P53-25 LN 85264FN00; SN ISR51499, ARCH HBSAG QUAL; SN ISR51499, ARCH HBSAG QUAL; SN ISR51499, ARCH HBSAG QUAL