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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 C (501) MODULE CLINICAL CHEMISTRY ANALYZER

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ROCHE DIAGNOSTICS COBAS 6000 C (501) MODULE CLINICAL CHEMISTRY ANALYZER Back to Search Results
Model Number C501
Device Problems Gauges/Meters (462); Low Test Results (2458); Device Subassembly (3051)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/26/2017
Event Type  Malfunction  
Manufacturer Narrative

This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).

 
Event Description

The customer initially stated that they were getting questionable results for a total of 6 patient samples tested for nh3l ammonia (nh3) on a cobas 6000 c (501) module - c501. Of these 5 samples, 4 had erroneous results. The first sample had an erroneous initial result that was reported outside of the laboratory. It was not clear if the second, third, and fourth samples had any erroneous results that were reported outside of the laboratory. A clarification has been requested. The first sample initially resulted as 69. 7 ug/dl and this value was reported outside of the laboratory. The sample was repeated as the patient had a previous value 99. 9 ug/dl on (b)(6) 2017. The repeat result of the sample was 88. 5 ug/dl. The sample was repeated a second time, resulting as 160. 9 ug/dl. The sample was also repeated on a cobas 8000 series analyzer, resulting as 184. 8 ug/dl. The second sample initially resulted as 48. 6 ug/dl on (b)(6) 2017. The sample was repeated on a cobas 8000 series analyzer, resulting as 82. 6 ug/dl on (b)(6) 2017. The third sample initially resulted as 50. 7 ug/dl on (b)(6) 2017. The sample was repeated on a cobas 8000 series analyzer, resulting as 78. 0 ug/dl on (b)(6) 2017. No adverse events were alleged to have occurred with these patients. The nh3 reagent lot number was 207830. The reagent expiration date was asked for, but not provided. The field service engineer cleaned the analyzer with bleach, changed the gear pump head, and changed a manometer. On (b)(6) 2017, the customer stated that they received an erroneous nh3 result for the fourth patient sample. The sample initially resulted as 98. 7 ug/dl and repeated as 119. 2 ug/dl. The sample was also repeated on a cobas 8000 series analyzer, resulting as 134. 9 ug/dl.

 
Manufacturer Narrative

On (b)(6) 2017, the first patient sample had a ggt result of 2252. No units of measure were provided. A reagent and hardware issue can be excluded since control recovery is ok and the calibration was successful prior to and after the event. The root cause of the event is incorrect sample preparation. Labeling instructs the customer that ammonia concentrations can increase in vitro due to breakdown of nitrogen-containing plasma components. One known source of ammonia formation at storage higher than -38 °c is an increased g-glutamyltransferase activity leading to decomposition of glutamine.

 
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Brand NameCOBAS 6000 C (501) 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 Key6567290
MDR Text Key75178707
Report Number1823260-2017-01006
Device Sequence Number0
Product Code JIF
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK060373
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 06/05/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/15/2017
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberC501
Device Catalogue Number04745914001
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 Received04/27/2017
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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