MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREATINE KINASE; DIFFERENTIAL RATE KINETIC METHOD, CPK OR ISOENZYMES

Catalog Number 04524977190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2015

Event Type  malfunction  

Manufacturer Narrative

Investigations were able to confirm the customer's ck results.A specific root cause could not be determined.The root cause of the lower concentration of ck was neither related to the hardware or to an interference.The root cause may be related to pre- analytic sample handling.Both sample types, serum and heparin plasma, are specified for both tests.K patient results are lower in heparin plasma samples could be explained in general by the different reference ranges for serum and plasma (serum: 3,5 - 5,01 mmol/l, plasma: 3,4 - 4,5 mmol/l).The root cause of the lower concentration of ckl was neither related to the hardware nor to an interference e.G.Heparin and might be related to pre- analytics.

Manufacturer Narrative

The units of measure used for the ise potassium test are mmol/l.

Event Description

The customer reported that they received erroneous creatine kinase (ck) and ion selective electrode (ise) potassium results when comparing the results from two different sample tubes from the same sample collection of the same patient.One tube was a serum tube and the other tube was a lithium heparin plasma tube.Both tubes were tested on a c501 analyzer.All results were reported outside of the laboratory.This medwatch will cover the ck test.Refer to the medwatch with patient identifier (b)(6) for information related to the ise potassium test.The serum tube initially resulted as 207 u/l for ck and 4.38 for ise potassium.No units of measure were provided for the ise potassium test.A clarification has been requested.The lithium heparin plasma tube initially resulted as 138 u/l for ck and 3.78 for ise potassium.The serum tube was repeated and resulted as 209 u/l for ck.The lithium heparin plasma tube was repeated and resulted as 146 u/l for ck.The lithium heparin plasma tube was repeated on (b)(6) 2015 and resulted as 134 u/l for ck.The field service representative replaced the gear pump head of the analyzer.It was noted that the gear pump head was in very good condition.The tubes were repeated after the gear pump head replacement on (b)(6) 2015.The lithium heparin plasma tube resulted as 138 u/l for ck and 5.01 for ise potassium when repeated on (b)(6) 2015.The serum tube resulted as 201 u/l for ck when repeated on (b)(6) 2015.The serum tube resulted as 200 u/l for ck and 5.37 for ise potassium when repeated for a second time on (b)(6) 2015.The patient was not adversely affected.The c501 analyzer serial number was (b)(4).

Manufacturer Narrative

This event occurred in (b)(6).

• Brand Name: CREATINE KINASE
• Type of Device: DIFFERENTIAL RATE KINETIC METHOD, CPK OR ISOENZYMES
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 6830 5; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 4666826
• MDR Text Key: 13161316
• Report Number: 1823260-2015-02830
• Device Sequence Number: 1
• Product Code: JHS
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K951595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04524977190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 03/19/2015
• 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
• Patient Sequence Number: 1