MAUDE Adverse Event Report: ABBOTT GERMANY ARCHITECT CORE; ANTI-HBC

Catalog Number	06L22-25
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/24/2017
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 is requesting an explanation for why the architect total anti-hbcore is nonreactive on a patient, but the architect anti-hbcore igm is reactive.The results provided were: anti-hbcore-m =1.62s/co (>/=1.21s/co = reactive); ausab = >1000.There was no reported impact to patient management.There was no additional patient information provided.
Additional Manufacturer Narrative
Potential false non-reactive results for one patient sample when using architect core reagent, list number 6l22-25, lot number 74196li00 compared to reactive core-m results.A review of tickets determined that there is normal complaint activity for lot number 74196li00 and no trends were identified for the complaint issue.Sensitivity testing was performed with a retained kit of lot 74196li00 by testing two commercially available seroconversion panels (biomex scp-hbv-001 and 004).The lot detected the same bleeds of the seroconversion panels as reactive with comparable s/co values.Manufacturing documentation of lot 74196li00 has been reviewed and no contributing factors to the complaint could be identified.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for architect core reagent, list number 6l22-25, lot number 74196li00.
Additional Manufacturer Narrative
Suspect medical device; lot# from unknown to 74196li00.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
Suspect medical device: brand name from anti-hbc to architect core; and common device name from architect core to anti-hbc.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

• Brand Name: ARCHITECT CORE
• Common Device Name: ANTI-HBC
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 7113567
• Report Number: 3002809144-2017-00163
• Device Sequence Number: 19306763
• Product Code: LOM
• UDI-Device Identifier: 00380740011123
• UDI-Public: 00380740011123
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/07/2018

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 Expiration Date: 02/08/2018
• Device Catalogue Number: 06L22-25
• Device Lot Number: 74196LI00
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/20/2017
• Supplement Date Received by Manufacturer: 12/19/2017; 02/02/2018; 02/06/2018
• Initial Report FDA Received Date: 12/13/2017
• Supplement Report FDA Received Date: 01/12/2018; 02/02/2018; 02/07/2018
• 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 I1000SR ANALYZER, LIST # 01L86-01:; ARCHITECT I1000SR ANALYZER, LIST # 01L86-01:; ARCHITECT I1000SR ANALYZER, LIST # 01L86-01:; ARCHITECT I1000SR ANALYZER, LIST # 01L86-01:; SERIAL # (B)(4); SERIAL # (B)(4); SERIAL # (B)(4); SERIAL # (B)(4)