MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CHOL2; ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL

Catalog Number	03039773190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas integra 400 plus serial number was (b)(6).Calibration and qc were acceptable.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 1 patient's serum sample tested with chol hico gen.2 (chol2) assay on a cobas integra 400 plus analyzer.Initial result: 615.10 mg/dl (accompanied by a data flag).The patient questioned the result and on (b)(6) 2024 the sample was then repeated.Repeat result: 179.13 mg/dl.
Additional Manufacturer Narrative
Correction: the cobas integra 400 plus serial number was (b)(6).A general reagent problem can be excluded because calibration and quality control were acceptable.The frequent occurrence of the "filling volume/no fluid" alarm was consistent with incorrect filled tubes or wrong tube configuration.The clotting time was low which was consistent with a general pre-analytical issue.The investigation did not identify a product problem.The root cause was consistent with a pre-analytical issue.

• Brand Name: CHOL2
• 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: 18739343
• Report Number: 1823260-2024-00489
• Device Sequence Number: 12573422
• Product Code: CHH
• UDI-Device Identifier: 04015630918430
• UDI-Public: 04015630918430
• Combination Product (Y/N): Y
• Initial Reporter Country: BA
• 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): 03/15/2024

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): Initial
• Initial Date Received by Manufacturer: 01/25/2024
• Supplement Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 27 YR
• Patient Sex: Male