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

Catalog Number	05401470190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable creatinine plus ver.2 results from the cobas c 111 analyzer.Sample 1 initial result using reagent lot 77882101 was 1.57 mg/dl and the repeat result was 0.77 mg/dl.On (b)(6) 2024, sample 2 initial result using reagent lot 79431601 was 1.24 mg/dl and the repeat results were 0.64 mg/dl and 0.62 mg/dl.
Additional Manufacturer Narrative
The cobas c 111 analyzer serial number was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The analyzer's log files showed the customer was not deproteinizing the probes daily.Product labeling states "maintenance - deproteinizing the probe to maintain the efficiency of the analyzer, you must clean and deproteinize the probe regularly to prevent the build-up of contaminants; daily." the investigation noted that the customer's centrifugation speed was too high and they overfilled the patient sample tubes.The investigation determined the issue was due to pre-analytical handling issues at the customer site.Correct pre-analytic sample handling is within the customer's responsibility.The investigation determined there was no hardware malfunction and a general reagent issue could be excluded since the qc and calibration were inconspicuous.

• 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: 20409051
• Report Number: 1823260-2024-02929
• Device Sequence Number: 17762167
• Product Code: JFY
• UDI-Device Identifier: 04015630926862
• UDI-Public: 04015630926862
• Combination Product (Y/N): Y
• Initial Reporter Country: CO
• 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): 02/03/2025

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: 05401470190
• Device Lot Number: 77882101, 79431601
• 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: 09/17/2024
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 02/03/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SAMPLE 1: TRAMADOL.; SAMPLE 2: ANTIBIOTICS FOR URINARY TRACT INFECTION.
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Weight: 70 KG