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

Catalog Number	03039773190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c501 analyzer serial number is (b)(6).The field service engineer ran precision studies and these were within specifications.Calibration and control data were acceptable.Upon review of the alarm trace, no relevant alarms were observed.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for four patient samples tested with cholesterol gen.2 on a cobas 6000 c501 module.The first sample initially resulted in a cholesterol value of 5.5 mg/dl.The sample was repeated on (b)(6) 2024, resulting in a value of 211.3 mg/dl with a data flag.The sample was repeated on (b)(6) 2024, resulting in a value of 213.6 mg/dl with a data flag.The second sample initially resulted in a cholesterol value of 4.7 mg/dl.The sample was repeated on (b)(6) 2024, resulting in a value of 192.5 mg/dl with a data flag.The sample was repeated on (b)(6) 2024, resulting in a value of 192.5 mg/dl with a data flag.The third sample initially resulted in a cholesterol value of 5.6 mg/dl.The sample was repeated on (b)(6) 2024, resulting in a value of 163.0 mg/dl with a data flag.The sample was repeated on (b)(6) 2024, resulting in a value of 167.1 mg/dl with a data flag.The fourth sample initially resulted in a cholesterol value of 5.0 mg/dl.The sample was repeated on (b)(6) 2024, resulting in a value of 233.3 mg/dl with a data flag.The sample was repeated on (b)(6) 2024, resulting in a value of 229.2 mg/dl with a data flag.
Additional Manufacturer Narrative
The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: CHOLESTEROL GEN.2
• Common Device Name: ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL
• 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: 19793186
• Report Number: 1823260-2024-02090
• Device Sequence Number: 7252454
• Product Code: CHH
• UDI-Device Identifier: 04015630918430
• UDI-Public: 04015630918430
• 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): 08/08/2024

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: 03039773190
• Device Lot Number: 75174001
• 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: 06/26/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 08/08/2024
• 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