MAUDE Adverse Event Report: RANDOX LABORATORIES LTD LIQUID CARDIAC CONTROL LEVEL 2

Catalog Number CQ5052

Device Problems Nonstandard Device (1420); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Randox has previously issued a recall for liquid cardiac control level 3 cq5053 lot 4245ck under rec334 (fda reference number z-2575-2018) on the 08 june 2018.Under this investigation all lots were evaluated for vial to vial imprecision and all met acceptance criteria.Subsequently, a customer queried the recovery of troponin t in liquid cardiac control level 2 cq5052 lot 4244ck.The deviation in precision observed is up to 12%.While this has been determined as acceptable by randox in the previous investigation it is not meeting the customer's needs.During the investigation of the customer complaint, real time data became available which indicated that the median recovered value has shifted from target.While the analyte median value is recovering in range this indicated a further issue with the product.Variation or a decrease in recovery of troponin t in a quality control material could delay reporting of results to a clinician.A delay in reporting troponin t could result in a delay in confirmatory diagnosis of myocardial infarction.This delay could result in a delay in treatment of the patient.Given recent complaints about this analyte and the critical nature in diagnosing cardiac events, a decision has been made to remove the claims for this analyte permanently.

• Brand Name: LIQUID CARDIAC CONTROL LEVEL 2
• Type of Device: LIQUID CARDIAC CONTROL LEVEL 2
• Manufacturer (Section D): RANDOX LABORATORIES LTD; 55 diamond road; crumlin, northern ireland BT29 4QY; UK BT29 4QY
• Manufacturer (Section G): RANDOX LABORATORIES LTD; 55 diamond road; crumlin, northern ireland BT29 4QY; UK BT29 4QY
• Manufacturer Contact: maria kelly ; 55 diamond road; crumlin, BT29 -4QY ; UK BT29 4QY
• MDR Report Key: 7929582
• MDR Text Key: 123383355
• Report Number: 8020890-2018-00003
• Device Sequence Number: 0
• Product Code: JJY
• PMA/PMN Number: K110534
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Relabeling
• Type of Report: Initial
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: CQ5052
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 0