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

Model Number CREAJ

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated they received a discrepant result for two samples from the same patient tested with crej2 creatinine jaffé gen.2 on two cobas 8000 c 702 modules.The involved patient works as a race car mechanic and uses nitromethane as a cleaner.On the first week of (b)(6) 2020, the patient accidentally inhaled 100-200 cc.Of nitromethane.The patient started to feel bad, was vomiting strongly, and was dizzy.The patient went to a hospital.He was neurologically asymptomatic and hemodynamically stable, with "aht" and dyslipidemia.A first sample collected from the patient at this hospital resulted with a creatinine value of 21 mg/dl when tested on their c 702 analyzer.It was stated that leukocytosis without anemization is observed.The patient's doctors decided the patient needed hemodialysis and was transported to the customer site.At the customer site, a second sample was collected from the patient and tested on the complained c 702 analyzer, resulting with a creatinine value of 21 mg/dl.The 21 mg/dl value was reported outside of the laboratory.The sample was repeated on an ortho vitros analyzer, resulting with a creatinine value of 0.69 mg/dl.The repeat value of 0.69 mg/dl was believed to be correct.The patient did not receive hemodialysis.The customer believes the nitromethane caused interference with the roche creatinine assay.The serial number of the c 702 analyzer used at the first site (hospital) was requested, but not provided.The serial number of the c 702 analyzer used at the customer site was (b)(4).

Manufacturer Narrative

The investigation could not identify a product problem.The cause of the event could not be determined.Nitromethane is not a drug and can normally not be found in the body, so it is out of scope of drug interference disclaimers.

• 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
• MDR Report Key: 9823820
• MDR Text Key: 220792205
• Report Number: 1823260-2020-00716
• Device Sequence Number: 1
• Product Code: CGX
• Combination Product (y/n): N
• PMA/PMN Number: K951595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 04/22/2020

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 Model Number: CREAJ
• Device Catalogue Number: 06407137190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/24/2020
• Initial Date FDA Received: 03/12/2020
• Supplement Dates Manufacturer Received: 02/24/2020
• Supplement Dates FDA Received: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 31 YR