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

Catalog Number	04718917190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas c111 analyzer serial number was (b)(6).Qc was acceptable.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with cholesterol gen.2 (chol2) assay on a cobas c111 analyzer.Initial result: 385 mg/dl.The physician questioned the initial result and requested a repeat of the original sample.On 10-jun-2024: repeat result: 213 mg/dl.The repeat result was considered to be correct.
Additional Manufacturer Narrative
A general reagent issue can be excluded since the calibration and qc were acceptable.The alarm trace did not show any abnormality.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: CHOLESTEROL GEN.2
• Common Device Name: CHOLESTEROL ENZYMATIC TEST
• 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: 19644150
• Report Number: 1823260-2024-01897
• Device Sequence Number: 17786815
• Product Code: CHH
• UDI-Device Identifier: 04015630922062
• UDI-Public: 04015630922062
• Combination Product (Y/N): Y
• Initial Reporter Country: TC
• 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): 08/16/2024

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: 06/30/2024
• Device Catalogue Number: 04718917190
• Device Lot Number: 75398601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2024
• Supplement Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 08/21/2024
• 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