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

Catalog Number	04P54-25
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/29/2018
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.The issue was previously reported under mdr number 3008344661-2018-00096 under a different suspect device.
Event or Problem Description
The customer observed (b)(6) results while using architect hbsag confirmatory reagents.The following data was provided.Confirmatory test was (b)(6) however no specific values were provided.Test results for the patient using architect hbsag qualitative reagents were provided: sid (b)(6) tested (b)(6) 2018 initial (b)(6), repeat in duplicate was (b)(6) however only one (b)(6) repeat result was provided ((b)(6)) and was flagged as exp.Retesting after recentrifuging the specimen was (b)(6), the customer did not provide the value.A previous specimen tested (b)(6) 2018 was (b)(6) (sid (b)(6)).A subsequent specimen tested (b)(6) 2018 was also (b)(6) ((b)(6)).The customer stated the patient was (b)(6) three months before the current test and was (b)(6), however no specific value or method was provided.The patient was pregnant and was about to give birth when the initial specimen was drawn.No adverse impact to patient management was reported.
Additional Manufacturer Narrative
The hbsag confirmatory reagents being used were expired and were therefore not valid.Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of field data, and a review of labeling.No adverse trend was identified for the customer's issue.No return patient sample was available.Historical performance of the reagent lot was evaluated using world wide data.The patient data was analyzed and within established control limits.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.
Additional Manufacturer Narrative
Suspect medical device 4.Lot number was changed 76116fn00 from unknown.Suspect medical device 4.Concomitant / accessory ln 04p53-25 lot number was changed to 89069fn00 from unknown.Device evaluated by mfr: an evaluation is in process.

• 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: 8217679
• Report Number: 3008344661-2019-00002
• Device Sequence Number: 1670779
• Product Code: LOM
• UDI-Device Identifier: 00380740007799
• UDI-Public: 00380740007799
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/25/2019

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: 01/22/2018
• Device Catalogue Number: 04P54-25
• Device Lot Number: 76116FN00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/21/2018
• Supplement Date Received by Manufacturer: 01/09/2019; 01/22/2019
• Initial Report FDA Received Date: 01/04/2019
• Supplement Report FDA Received Date: 01/10/2019; 01/25/2019
• 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: ARCH I1000SR LN 01L86-01; ARCH I1000SR LN 01L86-01; ARCH I1000SR LN 01L86-01; LN 04P53-25 LN 89069FN00; LN 04P53-25 LN UNKNOWN; SN I1SR54272, ARCH HBSAG 89069FN00; SN I1SR54272, ARCH HBSAG QUAL; SN I1SR54272, ARCH HBSAG QUAL