ELECSYS VITAMIN D TOTAL II

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-04-02 for ELECSYS VITAMIN D TOTAL II manufactured by Roche Diagnostics.

Event Text Entries

[140621552] This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10


[140621553] The initial reporter stated that they have had ongoing issues with patient sample recovery for the elecsys vitamin d total gen. 2 assay on the cobas 6000 e 601 module. The customer provided data for 19 patient samples with erroneous vitamin d results. Refer to the attachment for all patient data. It was asked, but it is not known if any erroneous results were reported outside of the laboratory. There was no allegation of an adverse event. The customer stated that they checked the reagents for bubbles prior to loading them on the analyzer. The serial number of the e 601 analyzer is (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1823260-2019-01315
MDR Report Key8472954
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2019-04-02
Date of Report2019-06-13
Date of Event2019-03-06
Date Mfgr Received2019-03-11
Date Added to Maude2019-04-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactNA MICHAEL LESLIE
Manufacturer Street9115 HAGUE ROAD NA
Manufacturer CityINDIANAPOLIS IN 46250
Manufacturer CountryUS
Manufacturer Postal46250
Manufacturer Phone3175214343
Manufacturer G1ROCHE DIAGNOSTICS GMBH
Manufacturer StreetSANDHOFERSTRASSE 116 NA
Manufacturer CityMANNHEIM (BADEN-WURTTEMBERG) 68305
Manufacturer CountryGM
Manufacturer Postal Code68305
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameELECSYS VITAMIN D TOTAL II
Generic NameVITAMIN D TEST SYSTEM
Product CodeMRG
Date Received2019-04-02
Model NumberNA
Catalog NumberASKU
Lot Number366696
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerROCHE DIAGNOSTICS
Manufacturer Address9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-02

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