MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREJ2 CREATININE JAFFÉ GEN.2 - COMPENSATED METHOD FOR SERUM AND PLASMA; ALKALINE PICRATE, COLORIMETRY, CREATININE

Model Number CREAJ

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2019

Event Type  malfunction  

Manufacturer Narrative

The customer stated that the previous calibration values were slightly high in december with acceptable results and that after the recalibration, the values appeared closer to the expected values with acceptable results.The qc was in acceptable range the day of the event.The field service engineer verified the instruments performance and completed a 21-cup precision with acceptable results.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter received questionable crej2 creatinine jaffé gen.2 - compensated method for serum and plasma results, for 3 samples from the same patient, from the cobas integra 400 plus serial number (b)(4).Sample 1: the initial result was 0.84 mg/dl and the rerun result was 1.07 mg/dl.Sample 2: the initial result was 0.96 mg/dl and the rerun result was 1.23 mg/dl.Sample 3: the initial result was 1.32 mg/dl and the repeat result was 1.65 mg/dl.All initial results were obtained prior to the calibration of a new reagent and all repeat results were obtained after a calibration of a new reagent.The initial results were not believed to be correct.The questionable results were reported outside the laboratory.

• Brand Name: CREJ2 CREATININE JAFFÉ GEN.2 - COMPENSATED METHOD FOR SERUM AND PLASMA
• 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: 9559841
• MDR Text Key: 216205855
• Report Number: 1823260-2020-00085
• Device Sequence Number: 1
• Product Code: CGX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K941837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/07/2020

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: 04810716190
• Device Lot Number: 324169
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2019
• Initial Date FDA Received: 01/07/2020
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1