ALBP ALBUMIN BCP ALB BCP

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 ALBP ALBUMIN BCP ALB BCP manufactured by Roche Diagnostics.

Event Text Entries

[143410033] For two events the investigations are ongoing. The follow up/corrective actions: none listed. 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


[143410034] This report summarizes 2 malfunction events. Erroneous low results were generated by the cobas 6000 c (501) module. The events involved a total of 2 patients with low results for albp albumin bcp. The patients' ages ranged were "newborns".
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1823260-2019-90096
MDR Report Key8551515
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 Report3

Device Details

Brand NameALBP ALBUMIN BCP
Generic NameBROMCRESOL PURPLE DYE-BINDING, ALBUMIN
Product CodeCJW
Date Received2019-04-25
Model NumberALB BCP
Lot Number382380, 350769
Device Availability*
Device AgeDA
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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