MAUDE Adverse Event Report: ROCHE DIAGNOSTICS HDL-CHOLESTEROL GEN.4; HDL CHOLESTEROL TEST SYSTEM

Catalog Number	08057877190
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The calibration and qc were acceptable.A general reagent issue was excluded.The system's alarm trace showed multiple "abnormal sample aspiration" alarms.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable hdl-cholesterol gen.4 results for 1 patient sample on a cobas c 303 analytical unit.The initial result was 3.18 mmol/l.The customer considered the result to be unacceptably high and repeated the sample.On (b)(6) 2024 the repeated result was 1.64 mmol/l.
Additional Manufacturer Narrative
D4 expiration date was updated.The investigation found the centrifugation speed was too slow.The investigation determined the issue was consistent with a pre-analytical handling issue.

• Brand Name: HDL-CHOLESTEROL GEN.4
• Common Device Name: HDL CHOLESTEROL 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: 21082972
• Report Number: 1823260-2025-00034
• Device Sequence Number: 8497687
• Product Code: LBS
• UDI-Device Identifier: 07613336121306
• UDI-Public: 07613336121306
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• PMA/510(K) Number: K162593
• 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): 01/24/2025

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: 03/31/2026
• Device Catalogue Number: 08057877190
• Device Lot Number: 794946
• 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: 12/11/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 01/24/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ALOPURINOL BELUPO; AMARYL; DILATREND; FORXIGA; GLUCOPHAGE; KAMIREN; PRADAXA; PRENEWEL; PROSTIDE; SORVASTA
• Patient Sex: Unknown