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

Catalog Number	08057532190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas pro c 503 analytical unit was with a serial number of (b)(6).On the day of the event, the alarm trace showed several alarms including abnormal aspiration and sample short alarms.The field service enginer (fse) checked the gauge pressure and the probe adjustments.The fse adjusted the main water pressure to the recommended specification.The fse checked the instrument and did not find any hardware issues.Calibration and qc were performed and they were acceptable after running the new reagent pack.Precision studies were performed and they were within specifications.The service actions done by the fse resolved the issue.H3 other text.
Event or Problem Description
We received an allegation about discrepant results for 2 patients' samples tested with creatinine (creaj2) assay on a cobas pro c 503 analytical unit compared to a different analyzer.Sample 1: initial result: 1.5 mg/dl, rerun result: 0.86 mg/dl.Sample 2: initial result: 1.21 mg/dl, rerun result: 0.8 mg/dl.The physician questioned the initial results.The repeat results were deemed to be correct.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17227704
• Report Number: 1823260-2023-02122
• Device Sequence Number: 7207332
• Product Code: CGX
• UDI-Device Identifier: 07613336121177
• UDI-Public: 07613336121177
• Combination Product (Y/N): N
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/29/2023

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 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): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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