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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INFINITY CORE SOFTWARE; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
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ROCHE DIAGNOSTICS COBAS INFINITY CORE SOFTWARE; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE Back to Search Results
Catalog Number 07154003001
Device Problem Application Program Version or Upgrade Problem (2881)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/14/2018
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6).
 
Event Description
The customer stated that when the software received an order for a sample type or multiple sample types from the same patient the result for one sample type was also attached to a different sample type.The customer stated that the issue occurred after performing a software upgrade to a new version.There was no allegation of an adverse event.No erroneous results were reported outside of the laboratory.The initial investigation confirmed that an additional configuration is required to prevent the issue.The investigation is ongoing.
 
Manufacturer Narrative
A software issue was not confirmed.When correctly configured, the software performed as intended.The investigation did not identify a product problem.
 
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Brand Name
COBAS INFINITY CORE SOFTWARE
Type of Device
CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
MDR Report Key8136869
MDR Text Key130042593
Report Number1823260-2018-04667
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 foreign,health professional,u
Type of Report Initial,Followup
Report Date 01/07/2019
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 Number07154003001
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 11/14/2018
Initial Date FDA Received12/06/2018
Supplement Dates Manufacturer Received11/14/2018
Supplement Dates FDA Received01/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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