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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS P 612 PRE-ANALYTICAL SYSTEM; AUTOMATED PREANALYTICAL SYSTEM
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ROCHE DIAGNOSTICS COBAS P 612 PRE-ANALYTICAL SYSTEM; AUTOMATED PREANALYTICAL SYSTEM Back to Search Results
Model Number P612
Device Problems Thermal Decomposition of Device (1071); Overheating of Device (1437)
Patient Problem No Patient Involvement (2645)
Event Date 11/26/2019
Event Type  malfunction  
Manufacturer Narrative
The field service engineer determined that a fuse failure caused a burn out in the fuse holder itself.There was a hole burned out on the back of the fuse holder.The engineer stated the ups system the customer was using was too old to hold a charge.After it was unplugged from the main power source, the ups was drained and unable to hold a charge.
 
Event Description
The initial reporter stated the cobas p 612 pre-analytical system turned off suddenly and the uninterruptible power supply (ups) system was not supplying power.There was a burning smell coming from the p 612 system.The reporter checked for evidence of fire beneath the system, but did not see anything.
 
Manufacturer Narrative
The investigation could not identify a product problem.The cause of the event could not be determined.
 
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Brand Name
COBAS P 612 PRE-ANALYTICAL SYSTEM
Type of Device
AUTOMATED PREANALYTICAL SYSTEM
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250
MDR Report Key9474377
MDR Text Key170915586
Report Number1823260-2019-04433
Device Sequence Number1
Product Code JQP
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 04/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberP612
Device Catalogue Number05082579001
Was Device Available for Evaluation? Yes
Date Manufacturer Received11/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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