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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 C 702 MODULE; CLINICAL CHEMISTRY ANALYZER
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ROCHE DIAGNOSTICS COBAS 8000 C 702 MODULE; CLINICAL CHEMISTRY ANALYZER Back to Search Results
Catalog Number 06473245001
Device Problem Low Test Results (2458)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/29/2024
Event Type  malfunction  
Event Description
There was an allegation of a questionable phosphorus result from the cobas 8000 c702 module.The initial result was 1.2 mmol/l and the repeat result was 1.7 mmol/l.
 
Manufacturer Narrative
The reagent lot number and expiration date were requested but were not provided.The field service engineer found a leak in two of the wash station hoses and replaced them.The investigation determined the maintenance actions resolved the issue.Reagent issues were excluded as the correct result was obtained on repeat testing using the same reagent.
 
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Brand Name
COBAS 8000 C 702 MODULE
Type of Device
CLINICAL CHEMISTRY ANALYZER
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
Manufacturer (Section G)
HITACHI HIGH TECH CORP.
882 ichige hitachinaka
ibaraki 312-8 504
JA   312-8504
Manufacturer Contact
amy nelson
9115 hague road
indianapolis, IN 46250
MDR Report Key18851437
MDR Text Key337076581
Report Number1823260-2024-00682
Device Sequence Number1
Product Code JJE
Combination Product (y/n)Y
Reporter Country CodeNL
PMA/PMN Number
K100853
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/06/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number06473245001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/29/2024
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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