MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREATININE JAFFÉ GEN. 2; ALKALINE PICRATE, COLORIMETRY, CREATININE

Catalog Number	ASKU
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable tina-quant cystatin c gen.2 and creatinine jaffé gen.2 results for 1 patient on a cobas 8000 c 701 module that were used to calculate the (gfr) glomerular filtration rate.The alleged calculated results did not fit the clinical status of the patient.Sample 1: on (b)(6) 2024 the cystatin c result was 2.65 mg/l.The calculated (gfr) glomerular filtration rate was 19.9 ml/min.Sample 2: on (b)(6) 2024 the cystatin c result was 2.38 mg/l.The calculated (gfr) glomerular filtration rate was 22.9 ml/min.The creatinine result was 0.88 mg/dl.The calculated (egfr) glomerular filtration rate was 72 ml/min.Sample 3: on (b)(6) 2024 the cystatin c result was 2.07 mg/l.The calculated (gfr) glomerular filtration rate was 27.6 ml/min.This medwatch will apply to the creatinine assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the tina-quant cystatin c gen.2 assay.The samples were repeated due to the patient having no known illnesses and did not take any medication.
Additional Manufacturer Narrative
The calibration and qc were acceptable.Gammopathy was excluded, although the kappa free light chain and gammaglobulin results are increased, visible in the electrophoresis results.Further investigation could not be performed due to the lack of information provided and the inability to send the sample.The investigation did not identify a product problem.

• Brand Name: CREATININE JAFFÉ GEN. 2
• Common Device Name: ALKALINE PICRATE, COLORIMETRY, 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: 20416205
• Report Number: 1823260-2024-02936
• Device Sequence Number: 8400685
• Product Code: CGX
• UDI-Device Identifier: 04015630930777
• UDI-Public: 04015630930777
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K951595
• 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): 11/05/2024

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: ASKU
• 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: 09/12/2024
• Supplement Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 11/05/2024
• 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: 60 YR
• Patient Sex: Female