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

Catalog Number	08057532190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The calibration was acceptable.The qc was within specification on the day of the event but was out of range after qc was repeated after the event.The reaction kinetics of the initial and repeat results did not indicate any issues.It was noted that yellow crystals were in the reagent.The alarm trace showed several "abnormal aspiration alarms" and "qc result out of range alarms" on the day of the event.The field service representative performed adjustments on the mixer and the photometer.The precision test results were acceptable.A new reagent lot was calibrated and qc was performed.The results were acceptable.A general reagent lot-specific issue was excluded.The investigation determined the issue was consistent with a storage/transport or handling issue of the reagent cassette.
Event or Problem Description
There was an allegation of questionable creatinine jaffe gen.2 results for an unknown number of patient samples on a cobas c 303 analytical unit.One example was provided: the initial result was 0.870 mg/dl.The repeated result was 1.20 mg/dl.This result was reported outside the laboratory.The sample was repeated because the questionable result did not match the patient's urea result and clinical history.

• 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: 20726857
• Report Number: 1823260-2024-03361
• Device Sequence Number: 21056238
• Product Code: CGX
• UDI-Device Identifier: 07613336121177
• UDI-Public: 07613336121177
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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
• Report Date (Section B): 11/19/2024

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 Expiration Date: 12/31/2025
• Device Catalogue Number: 08057532190
• Device Lot Number: 79469901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 11/19/2024
• 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