MAUDE Adverse Event Report: ROCHE DIAGNOSTICS LDLC3; LOW DENSITY LIPOPROTEIN TEST SYSTEM

Model Number	LDL-C G3
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2022
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem 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 ldl_c.Refer to medwatch with patient identifier (b)(6) for information on the hdlc3 results.

• Brand Name: LDLC3
• Common Device Name: LOW 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: 15887875
• Report Number: 1823260-2022-03817
• Device Sequence Number: 17419135
• Product Code: LBR
• UDI-Device Identifier: 04015630934591
• UDI-Public: 04015630934591
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K143691
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/30/2022

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
• Operator of Device: Health Professional
• Device Model Number: LDL-C G3
• Device Catalogue Number: 07005768190
• Device Lot Number: 59064401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown