MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREATININE PLUS VER.2; ENZYMATIC METHOD, CREATININE

Catalog Number	05168589190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received a questionable crep2 (creatinine) result from one patient sample tested on the cobas 8000 cobas c 701 module.On (b)(6) 2024: the initial result of the initial patient sample in a lithium heparinized tube was 63.57 mg/dl.On (b)(6) 2024: the repeat result in the lithium heparinized tube was 44.79 mg/dl.On (b)(6) 2024: the patient complained that the result from another hospital was normal.The repeat result of the initial patient sample in a dry tube was 8.39 mg/dl.The second repeat result of the initial patient sample in a dry tube was 8.57 mg/l.
Additional Manufacturer Narrative
The serial number of the cobas 8000 cobas c 701 module is (b)(6).The patient sample was requested for investigation.The investigation is ongoing.
Additional Manufacturer Narrative
The investigation excluded a general reagent issue because the calibration and qc results were according to specifications.The investigation excluded instrument-related issues because the results were reproducible when another patient sample was run.The investigation reviewed the image of the patient sample and found a gradient of cell debris on the surface.The investigation determined the event was consistent with a preanalytic issue at the customer site (cell debris on the surface of the patient sample).Preanalytics are within the customer's responsibility.There was no indication of a device malfunction.

• Brand Name: CREATININE PLUS VER.2
• Common Device Name: ENZYMATIC METHOD, CREATININE
• 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: 20035301
• Report Number: 1823260-2024-02445
• Device Sequence Number: 20476384
• Product Code: JFY
• UDI-Device Identifier: 04015630924998
• UDI-Public: 04015630924998
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• PMA/510(K) Number: K024098
• 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): 11/22/2024

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 Catalogue Number: 05168589190
• Device Lot Number: 809597
• 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: 08/02/2024
• Supplement Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 11/22/2024
• 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 Age: 26 YR
• Patient Sex: Female