MAUDE Adverse Event Report: DIASORIN, INC. THE PRO-TRAC II TACROLIMUS ELISA KIT; ENZYME IMMUNOASSAY, TACROLIMUS

Catalog Number 32400/32400-CN

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Incorrect Or Inadequate Test Results (2456); High Test Results (2457)

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

Event Type  malfunction  

Event Description

The pro-trac ii tacrolimus elisa kit is failing multiple internal specifications: absorbance of the calibrator zero (od), calibrator 1 (od) - calibrator 5 (od), calibrator 1 (od) - calibrator zero(od).Diasorin inc has confirmed that the failure manifests as a decrease in the total assay signal resulting in a shift in the calibration curve.This shift may cause discordant elevated tacrolimus results to be reported on a patient's sample.Evaluation summary attached.

Manufacturer Narrative

No customer reports of injury or illness have been received.This report does not reflect a conclusion by diasorin that this product caused or contributed to any alleged injury or illness.This report is being submitted in compliance with the mdr regulations.

• Brand Name: THE PRO-TRAC II TACROLIMUS ELISA KIT
• Type of Device: ENZYME IMMUNOASSAY, TACROLIMUS
• Manufacturer (Section D): DIASORIN, INC.; 1951 northwestern ave.; po box 285; stillwater MN 55082 028
• Manufacturer Contact: mari meyer ; 1951 northwestern ave.; po box 285; stillwater, MN 55082-0285 ; 6513515635
• MDR Report Key: 4616031
• MDR Text Key: 5654316
• Report Number: 2182595-2015-00001
• Device Sequence Number: 1
• Product Code: MLM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Not Applicable
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/30/2015
• Device Catalogue Number: 32400/32400-CN
• Device Lot Number: 131716/131717
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1