MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CHOL2; 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	01/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable chol2 cholesterol gen.2 results from 1 patient on a cobas 6000 c501 module.The customer suspects that there is an interfering factor in the patient sample.On (b)(6) 2023, the customer initially received a cholesterol result of 913 mg/dl with a flag indicating that the value was above the measuring range of the assay.After automatic dilution, the result was 892 mg/dl.A 1:20 manual dilution was performed and the result was around 1000 mg/dl.On (b)(6) 2023, another sample was collected and it gave a cholesterol result of 941 mg/dl with a flag indicating that the value was above the measuring range of the assay.After automatic dilution, the result was 996 mg/dl.A 1:20 manual dilution was performed and the result was around 1000 mg/dl.The results were reported outside of the laboratory.The analyzer serial number is (b)(4).
Additional Manufacturer Narrative
Calibration was last performed on 19-dec-2022.Qc recovery data was acceptable on both days of the event.Based on the calibration and qc data, a general reagent issue could be excluded.The investigation found that the customer has non-roche reagents on the analyzer which may cause unknown carry-over interference.The investigation also found that the gear pump head has never been replaced on the analyzer.The investigation is ongoing.
Additional Manufacturer Narrative
It was found that the customer was making a 1:20 dilution of the patient samples to reduce potential interference.Per product labeling, "determine samples having higher concentrations via the rerun function.Dilution of samples via the rerun function is a 1:10 dilution.Results from samples diluted using the rerun function are automatically multiplied by a factor of 10." the investigation did not identify a product problem.The root cause of the event could not be determined.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16287066
• Report Number: 1823260-2023-00329
• Device Sequence Number: 5020101
• Product Code: CHH
• UDI-Device Identifier: 04015630918430
• UDI-Public: 04015630918430
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• PMA/510(K) Number: K031824
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 03/17/2023

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: 05/31/2023
• Device Catalogue Number: 03039773190
• Device Lot Number: 65785501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2023
• Supplement Date Received by Manufacturer: 02/20/2023
• Initial Report FDA Received Date: 02/02/2023
• Supplement Report FDA Received Date: 03/17/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMLOR.; ASPIRIN.; CONCOR.; EMPAZA.; GALVUS.; URSOFALK.
• Patient Sex: Male