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

Model Number	LDL-C G3
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reaction monitor for ldlc3 showed that it began at higher absorbance and then decreased.The reaction monitor of hdlc4 also started at a higher absorbance and then decreased.The hdlc4 calibration from 18-nov-2022 to 25-jan-2023 was provided.The last hdlc4 calibration was within specifications.The ldlc3 calibration from 25-aug-2022 to 25-jan-2023 was provided.The last ldlc3 calibration was within specifications.The qc data for ldlc3 from 01-feb-2023 to 04-apr-2023 was provided.The recoveries of qc1 were within the +/-2 standard deviation (sd) range.The recoveries of qc2 were within the +/-2 standard deviation (sd) range.The qc data for hdlc4 from 01-feb-2023 to 04-apr-2023 was provided.The recoveries of qc1 were within the +/-2 standard deviation (sd) range.The recoveries of qc2 were within the +/-2 standard deviation (sd) range.The alarm trace on (b)(6) 2023 at 09:43 showed an "abnormal aspiration (sample probe b)" error.The measuring range of ldlc3 is 0.10-14.2 mmol/l (3.87-549 mg/dl), the patient's result of 0.36 is still within the measuring range.In addition, according to the ldlc3 application report, the technical range of the test is between 0-14.2 mmol/l.No data flag is expected for this result.Ldlc3 product labeling states "icterus: no significant interference up to an i index of 60 for conjugated and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 1026 mol/l or 60 mg/dl).Hemolysis: no significant interference up to an h index of 1000 (approximate hemoglobin concentration: 621 mol/l or 1000 mg/dl).Lipemia (intralipid): no significant interference up to an l index of 1000.There is poor correlation between the l index (corresponds to turbidity) and triglycerides concentration.".According to the hdlc4 application report, the technical range of the test is between 0-3.88 mmol/l.A flag (
Event or Problem Description
The initial reporter received questionable hdlc3 hdl-cholesterol plus 4th generation and ldl_c ldl-cholesterol plus 3rd generation results from two samples from the same patient tested on the cobas 8000 c702 module with serial number (b)(6).This mdr is for the ldlc3 assay.Please refer to mdr with a1 - patient identifier (b)(6) for the hdlc4 assay.Sample 1 the initial result was not reported outside of the laboratory as the results did not align with the patient's clinical picture.The reporter also stated that the hdlc4 and ldlc3 results did not agree with the elevated cholesterol and triglyceride results.The reporter stated that they did not perform any reruns for the patient sample.On (b)(6) 2023, the hdlc4 result was 0.05 mmol/l and the ldlc3 result was 0.36 mmol/l.The reporter then checked the reaction monitors and noted the absorbance was already high at the start of the reaction of the questionable results.The reporter was also concerned that questionable results were not flagged and no alarms were received from the module.The reporter stated that the sample was lipemic and hemolytic with the following indices: lipemia = 552; icterus = 2; hemolysis = 135.Sample 2 on (b)(6) 2023, the hdlc4 result was 0.11 mmol/l and the ldlc3 result was 0.87 mmol/l.The reporter stated that the lipemia in this sample was lower and the triglyceride result was lower than the results of the previous blood draw.
Additional Manufacturer Narrative
The investigation performed an experiment by adding asparaginase to the serum sample with a normal drug concentration for treatment and with a 100-fold higher drug concentration.The investigation determined that there is no evidence of interference with drug asparaginase in the reaction of the direct tests for hdl-c and ldl-c.The investigation determined that the event was related to the patient's condition, the investigation did not identify a product problem.

• 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: 16800426
• Report Number: 1823260-2023-01387
• Device Sequence Number: 20427602
• Product Code: LBR
• UDI-Device Identifier: 04015630934591
• UDI-Public: 04015630934591
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• PMA/510(K) Number: K143691
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2023

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 Expiration Date: 04/30/2024
• Device Model Number: LDL-C G3
• Device Catalogue Number: 07005768190
• Device Lot Number: 651456
• 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: 03/28/2023
• Supplement Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 04/24/2023
• Supplement Report FDA Received Date: 08/11/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PEG-ASPARAGINASE.
• Patient Age: 26 YR
• Patient Sex: Female