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

Catalog Number	06L22-25
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot/serial number was not provided by the customer; therefore, only a partial udi is known all available patient information was included.An evaluation is in process.A follow up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed a false negative hbcore result on the architect i2000sr analyzer.The following data was provided: sid (b)(6) initial 0.931, repeats 4.713, 4.927 s/co.There was no impact to patient management reported.
Additional Manufacturer Narrative
The suspect medical device was changed from ln 6l22-25 (unknown lot) to ln 08l44-30 lot 80236li00 on september 4, 2018 all follow up information will be provided in manufacturer report number 3002809144-2018-00373.

• 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: 7512743
• Report Number: 3002809144-2018-00050
• Device Sequence Number: 11111827
• Product Code: LOM
• UDI-Device Identifier: 00380740011123
• UDI-Public: 00380740011123
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2018

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: 06L22-25
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/19/2018
• Supplement Date Received by Manufacturer: 09/04/2018
• Initial Report FDA Received Date: 05/14/2018
• Supplement Report FDA Received Date: 09/24/2018
• 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 ANALYZER; ARCHITECT I2000SR ANALYZER; LN 03M74-01 SN (B)(4).; LN 03M74-01 SN (B)(4).