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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS BILT3 BILIRUBIN TOTAL GEN.3; DIAZO COLORIMETRY, BILIRUBIN
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ROCHE DIAGNOSTICS BILT3 BILIRUBIN TOTAL GEN.3; DIAZO COLORIMETRY, BILIRUBIN Back to Search Results
Catalog Number 05795397190
Medical Device Problem Code High Test Results (2457)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/24/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(6).
 
Event or Problem Description
The customer complained of discrepant bilt3 bilirubin total gen.3 results for 2 infants that were twins on a cobas 6000 c (501) module compared to a advanced bilirubin stat-analyzer model br-2.The c 501 serial number was (b)(4).There was no allegation of an adverse event.The initial investigation determined that the calibration was acceptable.
 
Additional Manufacturer Narrative
The investigation did not identify a product problem.The cause of the event could not be determined.
 
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Brand Name
BILT3 BILIRUBIN TOTAL GEN.3
Common Device Name
DIAZO COLORIMETRY, BILIRUBIN
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
MDR Report Key7778101
Report Number1823260-2018-02711
Device Sequence Number1318916
Product Code CIG
UDI-Device Identifier04015630928897
UDI-Public04015630928897
Combination Product (Y/N)N
Initial Reporter CountryRP
PMA/510(K) Number
K131544
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 09/26/2018
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
Operator of Device Health Professional
Device Catalogue Number05795397190
Device Lot Number281255
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 07/26/2018
Supplement Date Received by Manufacturer07/26/2018
Initial Report FDA Received Date08/13/2018
Supplement Report FDA Received Date09/26/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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