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

Catalog Number	07005768190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas 8000 c702 module is (b)(6).The serial numbers of the other facilities' cobas 8000 c702 modules were not provided.The customer has non-roche reagents/non-roche supported partner channels installed at the module.The investigation noted that the last calibration was performed on (b)(6) 2024, followed by daily blank calibrations.Product labeling states "calibration frequency 2-point calibration: - after reagent lot change.- as required following quality control procedures.The investigation reviewed the qc and the results were acceptable.The investigation reviewed the customer's handling of patient samples.The patient sample was collected in a gel blood collection tube, was inverted once, and was centrifuged for 5 minutes at 3500 rpm.The alarm trace contained multiple "sample short" and "abnormal aspiration" alarms.A general reagent problem was ruled out because the calibration and qc are acceptable.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable ldl-cholesterol gen.3 (ldlc3) results from one patient sample tested on an unspecified number of cobas 8000 c702 modules.The initial result from the module was 1.92 mmol/l.The repeat result from a non-roche reagent and platform was 9.32 mmol/l.The reporter stated that the patient's ldlc3 was retested in c702 modules in other facilities and the results were consistent.The initial result was not reported outside the laboratory as it did not meet the clinical diagnosis and they are considering lipoprotein x (lp-x) interference.
Additional Manufacturer Narrative
The investigation noted that the number of inversions and the centrifugation time of the patient sample were insufficient.A general reagent problem was excluded because calibration and qc are acceptable.The investigation determined the event was consistent with multiple user handling errors.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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21114657
• Report Number: 1823260-2025-00067
• Device Sequence Number: 7679461
• 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): 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): 02/14/2025

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: 01/31/2026
• Device Catalogue Number: 07005768190
• Device Lot Number: 813359
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 02/02/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 02/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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