MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREATININE PLUS VER.2; ENZYMATIC METHOD, CREATININE

Catalog Number 03263991190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer stated that they have received erroneous results for a total of 5 samples from the same patient tested for creatinine plus ver.2 (crep) on a c501 analyzer.All sample results were reported outside of the laboratory to the physician.No alarms occurred on the analyzer.It was stated that the blood samples were collected from an infusion port where dopamine was administered.It was stated that samples were collected 15 minutes after an infusion is stopped.(b)(6).The patient was not adversely affected.The c501 analyzer serial number was (b)(4).

Manufacturer Narrative

A specific root cause could not be determined based on the provided information.Based upon the information provided, calibration and quality controls are acceptable.A general reagent or hardware issue could be excluded.The patient sample was collected from the same intravenous catheter in which dopamine was administered.Investigations have determined that high catecholamine concentrations can lead to falsely low crep results.Dopamine and dobutamine at unusually high concentrations may interfere with peroxide based tests.In cases when high dosages of catecholamines are administered, no relevant interference could be found if the blood sample was not taken near the location of administration of catecholamine.

• Brand Name: CREATININE PLUS VER.2
• Type of Device: ENZYMATIC METHOD, 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: 5761446
• MDR Text Key: 48528654
• Report Number: 1823260-2016-00833
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K024098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03263991190
• Device Lot Number: 115655
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/06/2016
• 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
• Patient Age: 86 YR