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

Catalog Number	08057532190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable creaj2 (creatinine) results from the cobas pro c 503 analytical unit.Sample 1 initial result was 3.14 mg/dl and the repeat result was 0.84 mg/dl.Sample 2 initial result was 3.04 mg/dl and the repeat result was 0.77 mg/dl.The repeat results were believed correct.
Additional Manufacturer Narrative
The analyzer serial number was (b)(6).The field service engineer checked the analyzer and could not find a cause.He checked all components, secured all fittings, and checked the external probe rinse levels, cuvette rinse levels, photometer absorbance, gear pump pressures, and probe alignments.He replaced the reagent and sample probes and performed alignments.He adjusted the gear pump and changed the incubation bath and bath circulation.He performed precision testing, hardware checks, calibration, and qc.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 18066640
• Report Number: 1823260-2023-03513
• Device Sequence Number: 7593640
• Product Code: CGX
• UDI-Device Identifier: 07613336121177
• UDI-Public: 07613336121177
• Combination Product (Y/N): Y
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K951595
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/03/2023

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: 03/31/2025
• Device Catalogue Number: 08057532190
• Device Lot Number: 73634001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 11/03/2023
• 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: 40 YR
• Patient Sex: Male