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

Model Number CREAJ

Device Problem Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/20/2022

Event Type  malfunction  

Event 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).

Manufacturer Narrative

The investigation is ongoing.

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
• Type of Device: 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
• MDR Text Key: 301990120
• Report Number: 1823260-2022-01777
• Device Sequence Number: 1
• Product Code: CGX
• UDI-Device Identifier: 04015630922284
• UDI-Public: 04015630922284
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K941837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 05/26/2022
• Initial Date FDA Received: 06/17/2022
• Supplement Dates Manufacturer Received: 07/11/2022
• Supplement Dates FDA Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BACLOFEN; DEXAMETHASONE; DIAZEPAM; DIPYRONE; FUROSEMIDE; METHADONE; OMEPRAZOLE; ONDANSETRON; PARACETAMOL; SPIRONOLACTONE; VALPROIC ACID
• Patient Age: 5 YR
• Patient Sex: Female