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

Catalog Number	08057532190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the c 503 analyzer is (b)(6).Calibration and control data were acceptable.Upon review of the alarm trace, several abnormal aspiration alarms were observed on the day of the event.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with creatinine jaffe gen.2 on a cobas c 503 analytical unit.The sample initially resulted in a creatinine value of 0.93 mg/dl.The value did not agree with the historical data of the patient.The patient sample was repeated, resulting in a creatinine value of 0.13 mg/dl.
Additional Manufacturer Narrative
Calibration and control data were acceptable.A general reagent issue can be ruled out.Upon review of the alarm trace, several abnormal aspiration alarms were observed on the day of the event.Abnormal aspiration alarms were also present for several days.These alarms indicate potential pre-analytic handling issues.Two sets of precision studies were performed.The first study indicated that pipetting precision needed to be improved.The second study was acceptable.The investigation did not identify a product issue.The issue is consistent with insufficient pre-analytic sample handling.

• Brand Name: CREATININE JAFFE GEN.2
• Common Device Name: CREATININE, ALKALINE PICRATE COLORIMETRY
• 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: 20417651
• Report Number: 1823260-2024-02943
• Device Sequence Number: 15527667
• Product Code: CGX
• UDI-Device Identifier: 07613336121177
• UDI-Public: 07613336121177
• Combination Product (Y/N): Y
• Initial Reporter Country: EC
• 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): 10/18/2024

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: 08057532190
• 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: 09/20/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 10/18/2024
• 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