MAUDE Adverse Event Report: ROCHE DIAGNOSTICS HDLC4; HIGH DENSITY LIPOPROTEIN TEST SYSTEM

Model Number HDL-C G4

Device Problem Non Reproducible Results (4029)

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

Event Date 11/07/2022

Event Type  malfunction  

Event Description

There was an allegation of discrepant hdlc3 hdl-cholesterol plus 4th generation and ldl_c ldl-cholesterol plus 3rd generation results for 1 patient sample on a cobas 8000 c702 module compared to a beckman analyzer.The hdl result from the roche analyzer was 0.26 mmol/l.The hdl result from the beckman analyzer was 1.39 mmol/l.The roche hdl reference range is 1.31 - 3.29 mmol/l.The beckman hdl reference range is 1.03 - 1.55 mmol/l.The ldl result from the roche analyzer was 4.72 mmol/l.The ldl result from the beckman analyzer was 21.92 mmol/l.The roche ldl reference range is 1.31 - 3.29 mmol/l.The beckman ldl reference range is 1.89 - 4.21 mmol/l.No questionable results were reported outside of the laboratory.The c702 analyzer serial number is (b)(4).This medwatch will cover hdl3c.Refer to medwatch with patient identifier (b)(6) for information on the ldl_c results.

Manufacturer Narrative

The investigation found that the values measured for cholesterol may be interfered with by bilirubin because cholestasis is consistent with elevated levels of bilirubin depending on the disease stage.Therefore, the cholesterol values should only be reported by the laboratory if the concentration of bilirubin is below the allowable interference limit for the cholesterol assay.The patient's bilirubin results were not provided.Under the disease status of cholestasis, there is severe liver damage and liver dysfunction.It is reported in the literature that patients with cholestasis exhibit very high levels of cholesterol.Therefore, the values for cholesterol would fit the diagnosis of the disease.Since the liver, the central organ for lipid metabolism and for the uptake and synthesis of lipoproteins, is impaired in the disease state of cholestasis, the measurement of hdl-c and ldl-c is of no medical value.This is described in the ifus for roche hdlc4 and ldlc3 assays.It can be expected that patient samples with cholestasis will contain lp(x) particles and other abnormal lipoprotein fractions.The root cause of the event was found to be consistent with interfering factors related to the patient's diagnosis.The investigation did not identify a product problem.

• Brand Name: HDLC4
• Type of Device: HIGH DENSITY LIPOPROTEIN TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15887847
• MDR Text Key: 307610061
• Report Number: 1823260-2022-03818
• Device Sequence Number: 1
• Product Code: LBS
• UDI-Device Identifier: 04015630942572
• UDI-Public: 04015630942572
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K162593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HDL-C G4
• Device Catalogue Number: 07528582190
• Device Lot Number: 57273601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1