MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CHOLESTEROL GEN.2; CHOLESTEROL, ENZYMATIC

Catalog Number	08057443190
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	11/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable cholesterol gen.2 results from the cobas c 503 analytical unit.The initial result was 29.0 mg/dl.The repeat result was 178 mg/dl which was considered to be correct.The questionable result was not reported outside of the laboratory.
Additional Manufacturer Narrative
The cobas c 503 analytical unit serial number was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
Medwatch fields d4 lot no and d4 expiration date were updated.A general reagent problem was excluded because calibration and quality control were acceptable.The analyzer alarm trace contained frequent abnormal sample aspiration alarms.The event was consistent with pre-analytical handling issues at the customer site.Correct pre-analytic sample handling is within the customer's responsibility.Based on the provided data, the cause of the event could not be determined.The investigation did not identify a product problem.

• Brand Name: CHOLESTEROL GEN.2
• Common Device Name: CHOLESTEROL, ENZYMATIC
• 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: 20916870
• Report Number: 1823260-2024-03635
• Device Sequence Number: 8286364
• Product Code: CHH
• UDI-Device Identifier: 07613336121115
• UDI-Public: 07613336121115
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• PMA/510(K) Number: K031824
• 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): 01/10/2025

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: 04/30/2025
• Device Catalogue Number: 08057443190
• Device Lot Number: 812043
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 01/10/2025
• 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