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

Catalog Number 05168589190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/17/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(6).

Event Description

The customer stated that they received an erroneous result for one patient sample tested for creatinine plus ver.2 (crep) on a c701 analyzer.The customer suspects that the dobutamine drug that the patient was taking may be interfering with the crep test.The patient initially had a sample which resulted as 450 umol/l for crep and 40 umol/l for urea.These results were said to be ok given the clinical context of the patient.The patient has renal disease.The patient then received an injection of dobutamine.A new sample from the patient was collected and tested, resulting as 95 umol/l for crep and 40 umol/l for urea.The crep result of 95 umol/l for the new sample was reported outside of the laboratory.The new sample was diluted 1:15 and repeated, resulting as "around 250 umol/l" for crep.The patient was not adversely affected.The c701 analyzer serial number was (b)(4).

Manufacturer Narrative

A specific root cause could not be determined based on the provided information.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: COBAS INTEGRA CREATININE PLUS VER.2 ASSAY
• 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: 5563836
• MDR Text Key: 42215514
• Report Number: 1823260-2016-00416
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05168589190
• Device Lot Number: 620823
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2016
• 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
• Treatment: KARDÉGIC
• Patient Age: 88 YR