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

Catalog Number 03263991190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer reported that they had an erroneous creatinine plus ver.2 (creat) and an erroneous ion selective electrode (ise) potassium result for one patient sample tested on a c501 analyzer.The sample was collected from the infusion arm of the patient and this infusion contained dopamine.This medwatch will refer to creat.Please refer to the medwatch with patient identifier (b)(6) for information related to ise potassium.The sample resulted as 146.500 umol/l for creat and 4.470 mmol/l for ise potassium on (b)(6) 2015.The initial results were reported outside of the laboratory.The patient was said to usually have a creat value of 312 umol/l, so the initial creat value was questioned by the doctor.A new sample was collected from the patient 3 hours later from the other arm.The new sample resulted as 328.4 umol/l for creat and 5.450 mmol/l for ise potassium on (b)(6) 2015.The patient was not adversely affected.The c501 analyzer serial number was (b)(4).The customer stated that they performed a study where samples were diluted with a 1% infusion solution of 5 mg/ml dobutamide.Samples diluted in this fashion resulted with lower creat concentration.Diluting samples with a 0.5% infusion solution also resulted in lower creat concentration.No specific data was provided for this study.

Manufacturer Narrative

A specific root cause could not be determined based on the provided information.The false low results were most likely caused by inappropriate blood drawing techniques.It was stated in the investigation that blood should never be collected proximal to the infusion site as it may cause partial dilution of the sample.Samples should always be collected from the opposite arm.

• 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: 5407084
• MDR Text Key: 37440878
• Report Number: 1823260-2016-00097
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K024098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2016

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 Catalogue Number: 03263991190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2016
• Initial Date FDA Received: 02/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/16/2016
• 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: 89 YR