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

Model Number HDL-C G4

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 12/20/2022

Event Type  malfunction  

Manufacturer Narrative

Hdlc4 product labeling states: "ascorbic acid up to 50 mg/dl (2.84 mmol/l) does not interfere." ldl_c product labeling states: "ascorbic acid up to 50 mg/dl (2.84 mmol/l) does not interfere." calibration data was provided for (b)(6) 2022 and no issues were identified.Qc on the day of the event was acceptable.No issues were identified during a review of the alarm trace data.No pre-analytical issues were identified.The investigation is ongoing.

Event Description

The initial reporter complained of discrepant results for 1 patient sample tested for ldl_c ldl-cholesterol plus 2nd generation (ldl_c) on a cobas 8000 c 702 module compared to a non-roche method.Of the data provided, discrepant results for hdl-cholesterol gen.4 (hdlc4) were identified.This medwatch will cover hdlc4.Refer to medwatch with a1 patient identifier (b)(6) for information on the ldl_c results.The ldl_c result from the c702 module was 97.6 mg/dl the ldl cholesterol result from the non-roche method was 316.0 mg/dl.The hdlc4 cholesterol result from the c702 module was 50.1 mg/dl.The hdl cholesterol result from the non-roche method was 27.9 mg/dl.The customer mentioned the product labeling lists an interference statement related to ascorbic acid.It was asked but it is not known if the patient is taking ascorbic acid.No questionable results were reported outside of the laboratory.The c702 module serial number was (b)(4).

Manufacturer Narrative

Hdlc4 product labeling states: "ascorbic acid up to 50 mg/dl (2.84 mmol/l) does not interfere." ldl_c product labeling states: "ascorbic acid up to 50 mg/dl (2.84 mmol/l) does not interfere." calibration data was provided for (b)(6) 2022 and no issues were identified.Qc on the day of the event was acceptable.No issues were identified during a review of the alarm trace data.No pre-analytical issues were identified.The investigation is ongoing.

Event Description

The initial reporter complained of discrepant results for 1 patient sample tested for ldl_c ldl-cholesterol plus 2nd generation (ldl_c) on a cobas 8000 c 702 module compared to a non-roche method.Of the data provided, discrepant results for hdl-cholesterol gen.4 (hdlc4) were identified.This medwatch will cover hdlc4.Refer to medwatch with a1 patient identifier (b)(6) for information on the ldl_c results.The ldl_c result from the c702 module was 97.6 mg/dl the ldl cholesterol result from the non-roche method was 316.0 mg/dl.The hdlc4 cholesterol result from the c702 module was 50.1 mg/dl.The hdl cholesterol result from the non-roche method was 27.9 mg/dl.The customer mentioned the product labeling lists an interference statement related to ascorbic acid.It was asked but it is not known if the patient is taking ascorbic acid.No questionable results were reported outside of the laboratory.The c702 module serial number was (b)(4).

Manufacturer Narrative

The initial report stated: "the initial reporter complained of discrepant results for 1 patient sample tested for ldl_c ldl-cholesterol plus 2nd generation (ldl_c) on a cobas 8000 c 702 module compared to a non-roche method." this should say: "the initial reporter complained of discrepant results for 1 patient sample tested for ldl-cholesterol gen.3 (ldlc3) on a cobas 8000 c 702 module compared to a non-roche method." note: any previous reference to ldl_c should actually be ldlc3.Ldlc3 product labeling states: "ascorbic acid: no significant interference from ascorbic acid up to a concentration of 500 mg/dl (28.4 mmol/l).".

Manufacturer Narrative

As calibration and qc were within specification and instrument maintenance is performed on a regular basis, an instrument issue can be excluded.The reagent is working within specification.Based on the information provided, possible interference with nitroglycerin can be excluded.Product labeling addresses ascorbic acid as an interfering substance.It is unclear if the patient was receiving ascorbic acid.The investigation determined the event was consistent with a patient sample-related issue.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: 16156439
• MDR Text Key: 308839873
• Report Number: 1823260-2023-00122
• Device Sequence Number: 1
• Product Code: LBS
• UDI-Device Identifier: 04015630942572
• UDI-Public: 04015630942572
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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,Followup,Followup
• Report Date: 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• 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: 628274
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2023
• 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
• Treatment: "NITROGLYCERIN DRUGS"; "NITROGLYCERIN DRUGS"; ASPIRIN; ASPIRIN