MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT ANTI-HCV

Catalog Number 06C37-78

Device Problem Low Test Results (2458)

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

Event Date 08/01/2019

Event Type  malfunction  

Manufacturer Narrative

Patient identifier = (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 6c37 that has a similar product distributed in the us, list number 1l79.

Event Description

The customer reported (b)(6) architect anti-hcv results on one patient.The results provided were: on (b)(6) 2019 (b)(6) on architect= (b)(6) / on (b)(6) 2019 the elisa method was weak (b)(6) and hcv antigen was (b)(6) / on (b)(6) 2019 elisa anti-hcv was again (b)(6).There was no reported impact to patient management.Clinical diagnosis of scarred uterus.

Manufacturer Narrative

A review of tickets determined that there is a normal complaint activity for lots 03531be00 / 03531be01(same bulk as 03531be00) and no trends were identified for the complaint issue.Return testing was not completed as returns were not available.Sensitivity testing was performed with a retained kit of lot 03531be00 and two sensitivity panels (core only panel and ns3 only panel).Panels are internal measurement standards used to test product performance prior to lot release.The sensitivity panel values and positive control values met specifications.No false non-reactive results were obtained.In addition, the clinical sensitivity was evaluated by testing two commercially available seroconversion panels (zeptometrix hcv seroconversion panels hcv 9047 and hcv 9045).The seroconversion panel results were compared to historical architect anti-hcv test results provided by zeptometrix.Lot number 03531be00 detected the same bleeds as reactive for the seroconversion panels in comparison to historical data.Based on this data it was shown that the sensitivity performance is not adversely affected.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-hcv reagent, lot 03531be01.

• Brand Name: ARCHITECT ANTI-HCV
• Type of Device: ANTI-HCV
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9607223
• MDR Text Key: 217653258
• Report Number: 3002809144-2020-00061
• Device Sequence Number: 1
• Product Code: MZO
• 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: 01/29/2020

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: 01/04/2020
• Device Catalogue Number: 06C37-78
• Device Lot Number: 03531BE01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2020
• 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)(4); SERIAL # (B)(4)
• Patient Age: 36 YR