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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER

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ROCHE DIAGNOSTICS COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER Back to Search Results
Model Number C501
Device Problem High Test Results (2457)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/23/2016
Event Type  Malfunction  
Event Description

The customer stated that they received an erroneous result for one patient sample tested for nh3l ammonia (nh3) on a c501 analyzer. The sample initially resulted as 461. 0 umol/l and this value was reported outside of the laboratory to a physician. The patient was treated based on the initial result, but no details could be provided regarding the treatment that was provided. A second sample was collected from the patient for monitoring and this sample resulted as 28. 9 umol/l accompanied by a data flag on (b)(6) 2016. The second sample was diluted manually at a times three dilution, resulting with a raw value of 13. 5 on (b)(6) 2016. When accounting for the dilution factor, the diluted sample resulted with a final value of 40. 5 umol/l. The physician questioned the value obtained with the original sample since the result from the second sample was normal. The original sample was repeated on (b)(6) 2016, resulting as 30. 9 umol/l accompanied by a data flag. The original sample was repeated a second time, resulting as 50. 8 umol/l. A third sample was also collected from the patient and tested on (b)(6) 2016, resulting as 34. 8 umol/l accompanied by a data flag. The third sample was diluted manually at a times three dilution, resulting with a raw value of 12. 0 on (b)(6) 2016. When accounting for the dilution factor, the diluted sample resulted with a final value of 36. 0 umol/l. The repeat analysis of the original sample and results from the second and third samples were believed to be correct. It was asked, but it is not known if the patient was adversely affected due to receiving treatment. No adverse events were alleged to have occurred with this patient. The nh3 reagent lot number and expiration date were asked for, but not provided. The customer stated that one level of control was outside of range prior to the event. The field service representative could not find a cause for the event. He checked the operation of the instrument. The customer ran precision studies, calibration, and quality controls; all tests passed. During investigations, it was stated that the issue is likely related to pre-analytic sample handling since the affected sample was said to be only 1/4 full.

 
Manufacturer Narrative

A specific root cause could not be determined with the information provided for investigation. Additional information for further investigation was requested but not provided. Since the customer stated that the tube was only 1/4 full, a pre-analytic sample handling issue seems likely. No other patient results were questioned as values matched previous results. The product was found to meet specifications. Ammonia concentrations can increase in-vitro due to break down of nitrogen-containing plasma components. This may occur due to situations such as incorrect sample storage conditions or ammonia contamination from the environment.

 
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Brand NameCOBAS 6000 C501 MODULE
Type of DeviceCLINICAL CHEMISTRY ANALYZER
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
Manufacturer (Section G)
HITACHI HIGH TECH CORP.
882 ichige hitachinaka
na
ibaraki 312-8 504
JA 312-8504
Manufacturer Contact
michael leslie
9115 hague road
na
indianapolis, IN 46250
3175214343
MDR Report Key5939598
MDR Text Key54327125
Report Number1823260-2016-01342
Device Sequence Number0
Product Code JIF
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK060373
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 09/29/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/09/2016
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberC501
Device Catalogue Number05860636001
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2016
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

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