MAUDE Adverse Event Report: ABBOTT GERMANY ARCHITECT ANTI-HCV

Catalog Number 06C37-37

Device Problem Low Readings (2460)

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

Event Date 01/11/2019

Event Type  malfunction  

Manufacturer Narrative

All available patient information was included.Additional patient details are not available.An evaluation is in process.A final 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 observed (b)(6) architect anti-hcv results for a (b)(6) patient.The following data was provided (s/co): sid (b)(6): initial (b)(6), repeat (b)(6).Repeated on another lot as (b)(6).No impact to patient management was reported.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling and sensitivity testing.No adverse trend was identified for the customer's issue.Retained file kits of architect anti-hcv reagent lot numbers 94361li00 and 95367li00 were tested in a control setup.The two lot numbers were calibrated on three instruments and the calibrations met instrument specifications.To evaluate reagent performance, 18 replicates of positive control and negative control were tested across three instruments.Sensitivity testing met all specifications.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.

Manufacturer Narrative

A mistake was identified on feb 11, 2019.One of the repeat results listed was inadvertently a positive control result.To clarify: the information is not applicable repeated on another lot as 1.99 s/co as 1.99 is the value of positive control level and not the result of the repeated test of patient sample.An evaluation is still in process and a final report will be submitted when the evaluation is complete.

• Brand Name: ARCHITECT ANTI-HCV
• Type of Device: ANTI-HCV
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 8302165
• MDR Text Key: 134989110
• Report Number: 3002809144-2019-00042
• 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,Followup
• Report Date: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/22/2019
• Device Catalogue Number: 06C37-37
• Device Lot Number: 95371LI00
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER; ARCHITECT I2000SR ANALYZER; ARCHITECT I2000SR ANALYZER; LN 03M74-97 SN (B)(4); LN 03M74-97 SN (B)(4); LN 03M74-97 SN (B)(4)