MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT ANTI-HBC II

Catalog Number 08L44-78

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/30/2019

Event Type  malfunction  

Manufacturer Narrative

Patient identifier = sid = (b)(6).There was no further patient information provided by the customer.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 8l44 that has a similar product distributed in the us, list number 6l22.

Event Description

The customer reported (b)(6) architect anti- hbc results on one patient who was (b)(6) for (b)(6).The results provided were: on (b)(6) 2019 (b)(6) = (b)(6) / retested on a different analyzer (sn (b)(4)) = (b)(6).There was no reported impact to patient management.

Manufacturer Narrative

Lot # from 05149be01 to 05249be01.A review of tickets did not find any other complaints for lot 05249be00 and no trends were identified for the issue for the product.Return testing was not completed as returns were not available.Sensitivity testing was performed with a retained kit of lot 05249be00 (reagent lot 05249be00 and 05249be01 are identical except the china specific labeling of the outer package) and the results of this setup did not implicate that the sensitivity performance of the lot is negatively impacted.The reagent kit showed normal performance without false non-reactive results.In addition, the clinical sensitivity of the lot was evaluated by testing two commercially available seroconversion panels (biomex seroconversion panel scp-hbv-001 and scp-hbv-004).The seroconversion panel results were compared to architect anti-hbc ii test results provided by biomex.The lot detected the same bleeds as reactive for the seroconversion panels.Based on these data it was shown that the sensitivity performance of the lot is not impacted.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect anti-hbc ii reagent, lot 05249be01.

• Brand Name: ARCHITECT ANTI-HBC II
• Type of Device: ANTI-HBC
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9607243
• MDR Text Key: 219881604
• Report Number: 3002809144-2020-00063
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/27/2020
• Device Catalogue Number: 08L44-78
• Device Lot Number: 05249BE01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER, LN 03M74-02,; ARCHITECT I2000SR ANALYZER, LN 03M74-02,; SERIAL # (B)(6); SERIAL # (B)(6)