MAUDE Adverse Event Report: BIO-RAD LABORATORIES, INC. LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LEVEL 2; MUITI-ANALYTE CONTROLS, ALL KINDS (ASSAYED)

Model Number 147

Device Problem Burst Container or Vessel (1074)

Patient Problem Laceration(s) (1946)

Event Date 05/10/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023, an employee of siemens healthineers reported an accidental blood exposure and finger cut at laboratoire synlab sylab figeac at combe de lavayssière, 46100 figeac, france.The employee noted that while opening liquichek cardiac marker plus control lt, level 2, lot 67672 as part of a new automaton installation, the product bottle burst and caused cuts to the left index finger.A 5-day of antibiotics dose was given and tests for hiv, hcv, aghbs, and syphilis were conducted.Bio-rad technical service provided the product safety data sheet, as well as the instructions for use (ifu) and certificate of analysis for lot 67672.

Manufacturer Narrative

The instruction for use provided by bio-rad for testing the liquichek cardiac markers plus control lt indicated the product contains human source materials and should be considered potentially infectious and handled with the same precautions used with patient specimens in accordance with good laboratory practice.Each human donor unit used to manufacture this product was tested as required by fda accepted methods.Tests results were non-reactive for hepatitis b surface antigen (hbsag), antibody to hepatitis c (hcv), and antibody to hiv-1/hiv-2.This product may also contain other human source materials for which there are no approved tests.In accordance with good laboratory practice, all human source material should be considered potentially infectious and handled with the same precautions used with patient specimens.The company address information of the initial reporter was not provided to bio-rad.

• Brand Name: LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LEVEL 2
• Type of Device: MUITI-ANALYTE CONTROLS, ALL KINDS (ASSAYED)
• Manufacturer (Section D): BIO-RAD LABORATORIES, INC.; 9500 jeronimo rd; irvine CA 92618 2017
• Manufacturer (Section G): BIO-RAD LABORATORIES, INC.; 9500 jeronimo road; irvine 92618 2017
• Manufacturer Contact: maria zeballos ; 9500 jeronimo road; irvine, CA 92618-2017 ; 9499981200
• MDR Report Key: 16947420
• MDR Text Key: 315698428
• Report Number: 2016706-2023-00002
• Device Sequence Number: 1
• Product Code: JJY
• UDI-Device Identifier: 00847661000730
• UDI-Public: 00847661000730
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K050537
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 147
• Device Catalogue Number: 147
• Device Lot Number: 67672
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female