MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREJ2 CREATININE JAFFÉ GEN.2; ALKALINE PICRATE, COLORIMETRY, CREATININE

Model Number	CREAJ
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable crej2 creatinine jaffé gen.2 results for two samples from one patient.The customer questioned if the patient's medications/treatments could have affected the results.Sample 1 was drawn at 01:56 pm and the results were 6.16 mg/dl, 6.25 mg/dl, and 6.59 mg/dl.Sample 2 was drawn at 5:12 pm and the results were 0.27 mg/dl and 0.31 mg/dl.The questionable results were not reported outside of the laboratory.The customer used cobas 6000 c501 module serial number (b)(4).
Additional Manufacturer Narrative
The investigation is ongoing.
Additional Manufacturer Narrative
The analyzer alarm trace contained several abnormal probe sucking alarms on the date of the event.This is usually an indicator of a pre-analytical handling issue.The provided data for calibration and quality control were within the specification.Therefore a general reagent and/or system-related issue could be excluded.The investigation did not identify a product problem.The cause of the event could not be determined as no sample material was available for further investigation.

• Brand Name: CREJ2 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14735813
• Report Number: 1823260-2022-01777
• Device Sequence Number: 12274000
• Product Code: CGX
• UDI-Device Identifier: 04015630922284
• UDI-Public: 04015630922284
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K941837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 08/04/2022

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: 09/30/2023
• Device Model Number: CREAJ
• Device Catalogue Number: 04810716190
• Device Lot Number: 60357801
• 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: 05/26/2022
• Supplement Date Received by Manufacturer: 07/11/2022
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 08/04/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BACLOFEN; DEXAMETHASONE; DIAZEPAM; DIPYRONE; FUROSEMIDE; METHADONE; OMEPRAZOLE; ONDANSETRON; PARACETAMOL; SPIRONOLACTONE; VALPROIC ACID
• Patient Age: 5 YR
• Patient Sex: Female