MAUDE Adverse Event Report: ROCHE DIAGNOSTICS LDLC3 LDL-CHOLESTEROL GEN.3; LOW DENSITY LIPOPROTEIN TEST SYSTEM

Model Number LDL-C G3

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/27/2021

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The full facility name was provided as "((b)(6)) department of clinical pathology, faculty of (b)(6) hospital".Unique identifier (udi) # = (b)(4).

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with ldl_c ldl-cholesterol plus 3rd generation on a cobas 8000 c 702 module.The sample initially resulted with an ldl value of 18.5 mg/dl when tested on the c 702 analyzer.This initial value was reported outside of the laboratory.The sample was repeated on an abbott architect analyzer, resulting with an ldl value of 162.16 mg/dl.The serial number of the c 702 analyzer is (b)(4).

Manufacturer Narrative

Calibration and control data are acceptable, so a general reagent or instrument issue could be excluded.The clinical picture of the patient is alcoholic hepatitis.Based on that, it can be assumed that the patient's liver function is not normal.Abnormal liver function affects lipid metabolism; consequently hdl and ldl results are of limited diagnostic value.In some patients with abnormal liver function, the ldl cholesterol result is significantly negatively biased versus beta quantification results.The investigation could not identify a product problem.

• Brand Name: LDLC3 LDL-CHOLESTEROL GEN.3
• Type of Device: LOW DENSITY LIPOPROTEIN TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11378995
• MDR Text Key: 255856168
• Report Number: 1823260-2021-00581
• Device Sequence Number: 1
• Product Code: LBR
• Combination Product (y/n): N
• PMA/PMN Number: K143691
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: LDL-C G3
• Device Catalogue Number: 07005768190
• Device Lot Number: 44247801
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1