ELECSYS HGH ASSAY

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-25 for ELECSYS HGH ASSAY manufactured by Roche Diagnostics.

Event Text Entries

[143417074] The investigation could not identify a product problem. The cause of the event could not be determined. There were no follow up/corrective actions for this event. No devices were returned. This device is not labeled for single use and is not reprocessed or reused.
Patient Sequence No: 1, Text Type: N, H10


[143417075] This report summarizes 1 malfunction event. Non-reproducible results were generated by the cobas 6000 e 601 module or the cobas 8000 e 602 module. The event involved a total of 2 patients tested for elecsys hgh. The patients' ages ranged from (b)(6) - (b)(6). There was 1 male and 1 female.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1823260-2019-90133
MDR Report Key8549729
Date Received2019-04-25
Date Added to Maude2019-04-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactMICHAEL LESLIE
Manufacturer Street9115 HAGUE ROAD NA
Manufacturer CityINDIANAPOLIS IN 46250
Manufacturer CountryUS
Manufacturer Postal46250
Manufacturer Phone3175214343
Manufacturer G1ROCHE DIAGNOSTICS GMBH
Manufacturer StreetSANDHOFFERSTRASSE 116 NA
Manufacturer CityMANNHEIM (BADEN-WURTTEMBERG), NA 68305
Manufacturer CountryGM
Manufacturer Postal Code68305
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameELECSYS HGH ASSAY
Generic NameHUMAN GROWTH HORMONE ASSAY
Product CodeCFL
Date Received2019-04-25
Model NumberHGH
Lot Number286645
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerROCHE DIAGNOSTICS
Manufacturer Address9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-25

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