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

Catalog Number	03039773190
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	01/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable chol2 results for 1 patient sample on a cobas integra 400 plus module.The initial result was 527.92 mg/dl.The physician questioned the result and the sample was repeated.On (b)(6) 2024 the sample was repeated and the result was 263.83 mg/dl.
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The customer's calibration and qc results were ok.A precision check was performed and the results were acceptable.The investigation is ongoing.
Additional Manufacturer Narrative
Preventive maintenance was last performed in dec-2023.A general reagent problem can be excluded as calibration and quality control were acceptable.The investigation did not identify a product problem.The root cause was consistent with a customer's handling error / isolated pipetting error.

• 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: 18670733
• Report Number: 1823260-2024-00374
• Device Sequence Number: 8212190
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2024

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: 04/30/2024
• Device Catalogue Number: 03039773190
• Device Lot Number: 741392
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 02/08/2024
• Supplement Report FDA Received Date: 03/04/2024
• 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