MAUDE Adverse Event Report: ROCHE DIAGNOSTICS HOMOCYSTEINE ENZYMATIC ASSAY; URINARY HOMOCYSTINE (NONQUANTITATIVE) TEST SYSTEM

Model Number	08057826190
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable low results for an unspecified number of patient samples tested for homocysteine enzymatic assay (hcys) on a cobas pure analyzer compared to a high-performance liquid chromatography (hplc) method.Of the data provided for 11 patient samples, the results for 10 patient samples were discrepant.Refer to the attached data for the patient results.
Additional Manufacturer Narrative
The cobas pure analyzer serial number was not provided.
Additional Manufacturer Narrative
The customer used samples collected with sarstedt homocystein z-gel stabilized heparin tubes with gel.The sarstedt z-gel tube contains an inhibitor for hcy synthesis.All sample tubes containing hcy stabilizers of any kind are unsuitable for the roche hcy test, as they inhibit the detection reaction of the hcy test, which is very similar to the endogenous hcy synthesis.Product labeling states: "for specimen collection and preparation only use suitable tubes or collection containers.Only the specimens listed below were tested and found acceptable: serum, plasma: li-heparin, k2-edta and k3-edta plasma." the investigation did not identify a product problem.
Additional Manufacturer Narrative
The medical device problem, investigation findings, and investigation conclusion codes were updated.

• Brand Name: HOMOCYSTEINE ENZYMATIC ASSAY
• Common Device Name: URINARY HOMOCYSTINE (NONQUANTITATIVE) TEST SYSTEM
• 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: 19930753
• Report Number: 1823260-2024-02295
• Device Sequence Number: 2846986
• Product Code: LPS
• UDI-Device Identifier: 07613336121290
• UDI-Public: 07613336121290
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K113793
• 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,Followup
• Report Date (Section B): 11/04/2024

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 Model Number: 08057826190
• Device Catalogue Number: 08057826190
• Device Lot Number: ASKU
• 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: 07/18/2024
• Supplement Date Received by Manufacturer: 10/09/2024; 10/23/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 10/15/2024; 11/04/2024
• 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