MAUDE Adverse Event Report: QUEST LABORATORY INSTRUMENT FOR MEASURING KAPPA LIGHT CHAINS AND LAMBDA LIGHT CH; LAMBDA, ANTIGEN, ANTISERUM, CONTROL

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2021

Event Type  malfunction  

Event Description

Blood specimen (taken at physician's office by a quest employee) was sent to quest for a "kappa/lambda light chain free serum" test but instead of that test quest performed a "kappa/lambda light chain total serum" test.I left my home on (b)(6) 2021, specifically for this test to determine whether there is progression to multiple myeloma.In light of the ongoing omicron community transmission my physician advises that i wait until it is safe for me to again visit his office (or another facility where a blood specimen can be taken).My physician's order to quest was sent electronically and i personally confirmed with quest that their technician failed to perform the correct test.They indicated that he had not read the complete test name and so missed "free" and thus performed the "total" version of the test.Quest's failure to perform the test has resulted in a potential medical issue for me.The test is a ratio and so there are no units associated with the test.The ratio is a 'pure number." fda safety report id # (b)(4).

• Brand Name: QUEST LABORATORY INSTRUMENT FOR MEASURING KAPPA LIGHT CHAINS AND LAMBDA LIGHT CH
• Type of Device: LAMBDA, ANTIGEN, ANTISERUM, CONTROL
• MDR Report Key: 13290733
• MDR Text Key: 284285465
• Report Number: MW5106795
• Device Sequence Number: 1
• Product Code: DEH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/18/2022
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White