MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT HBSAG QUALITATIVE

Model Number	4P53-25
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: multiple = sids: (b)(6).All available patient information has been included.No additional patient details are available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer obtained false nonreactive architect hbsag qualitative results on two patients.The customer was initially questioning the big difference between the original reactive results (5.37 s/co) vs the repeats (41.55 / 37.80 s/co).This lead the customer into repeating the test the following day which generated nonreactive results.The following results were provided: on (b)(6) 2020, sid: (b)(6), generated initial result = 5.37 s/co (reactive), repeated 41.55 s/co (reactive), 37.80 s/co (reactive), 0.18 s/co (nonreactive), 0.17 s/co (nonreactive), confirmatory result = 0.74 s/co % neutralization = 106% (confirmed reactive).Sid: (b)(6), generated initial result = 2.90 s/co (reactive), repeated 1.71 s/co (reactive), 0.79 s/co (nonreactive), 31.75 s/co (reactive), 30.26 s/co (reactive), 10.41 s/co (reactive), 10.35 s/co (reactive); (reference range <1.00 = nonreactive, >/= to 1.00 = reactive).Sid: (b)(6) and sid: (b)(6) generated nonreactive results at a reference lab.The customer did not perform confirmatory testing for the sid (b)(6).No result was released to the provider.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation included a search for similar complaints, trending data, labeling, and device history records.A review of the results stated in the ticket text was also performed.In-house testing of reagent lot 15113fn00 was completed.Return testing was not completed as returns were not available.A review of tickets determined that there is normal complaint activity for the architect hbsag assay, lot number 15113fn00.Review of tracking and trending reports did not identify any related trends for the issue for the product.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.Labeling was reviewed and found to adequately address the issue under review.In house testing of panels which mimic patient samples was completed using retained samples of the complaint lot.All specifications were met indicating that the lot is performing acceptably.Based on the investigation, no systemic issue or deficiency of the architect hbsag assay, lot number 15113fn00 was identified.

• Brand Name: ARCHITECT HBSAG QUALITATIVE
• Common Device Name: HBSAG
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; diagnostics division; sligo F91VY 44; EI F91VY44
• MDR Report Key: 10576757
• Report Number: 3008344661-2020-00072
• Device Sequence Number: 16927648
• Product Code: LOM
• UDI-Device Identifier: 00380740007775
• UDI-Public: 00380740007775
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 12/14/2020

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: 12/04/2020
• Device Model Number: 4P53-25
• Device Catalogue Number: 04P53-25
• Device Lot Number: 15113FN00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/09/2020
• Supplement Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 09/23/2020
• Supplement Report FDA Received Date: 12/15/2020
• 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: ARC I2000SR RFB, 03M74-98, ISR04034-96; ARCHITECT I2000SR ANALYZER, LIST 03M74-98,; SERIAL(B)(6).