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U.S. Department of Health and Human Services

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

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ROCHE DIAGNOSTICS CREATINE KINASE; DIFFERENTIAL RATE KINETIC METHOD, CPK OR ISOENZYMES Back to Search Results
Catalog Number 04524977190
Device Problem Low Test Results (2458)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/18/2015
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6).
 
Event Description
The customer received questionable creatine kinase results for one patient sample from two cobas c501 analyzers.The initial result from cobas c501 serial number (b)(4) was 692.6 u/l with a data flag.The repeat testing gave no numeric result but a data flag.The sample was repeated on cobas c501 serial number (b)(4) and the result was 296.4 u/l which was reported outside the laboratory.Later in the day, a repeat sample was received for the patient and the customer decided to repeat the original sample.The sample was repeated on cobas c501 serial number (b)(4) and the results were 341 u/l with a data flag and no numeric result but a data flag.The sample was repeated on cobas c501 serial number (b)(4) and the results were 485.3 u/l with a data flag and no numeric result but a data flag.With a 1:20 dilution, the results in sample cups were 35748 u/l and 29164 u/l.The results with the dilution were believed to be correct and a corrected report was issued.The patient was not adversely affected.
 
Manufacturer Narrative
A specific root cause could not be identified.Based on the provided calibration, qc, and precision data, the instruments were working according to specifications.As only one sample was affected, the issue seems to be a preanalytic sample issue.
 
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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) 68305
GM   68305
Manufacturer Contact
michael leslie
9115 hague road
na
indianapolis, IN 46250
3175214343
MDR Report Key5160115
MDR Text Key28675583
Report Number1823260-2015-04354
Device Sequence Number1
Product Code JHS
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K951595
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Health Professional
Type of Report Followup
Report Date 12/16/2015
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 Number04524977190
Device Lot Number66033801
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Event Location Laboratory
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/19/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/16/2015
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
Type of Device Usage N
Patient Sequence Number1
Patient Age051 YR
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