COBAS INTEGRA 400 PLUS I400+ 03245233001

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 2017-09-26 for COBAS INTEGRA 400 PLUS I400+ 03245233001 manufactured by Roche Diagnostics.

Event Text Entries

[89487857] This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[89487858] The customer stated that they received an erroneous result for one patient sample tested for etoh2 ethanol gen. 2 (etoh) on a cobas integra 400 plus (i400+). The sample initially resulted as 0. 027 g/l and this value was reported outside of the laboratory to the hospital service. The doctor called back because the result was unbelievable. The doctor asked for a repeat of the sample and the repeat result was 2. 541 g/l. No adverse events were alleged to have occurred to the patient. The etoh reagent lot number was 24428401. The reagent expiration date was asked for, but not provided. Upon review of calibration data, the calibration is perfect.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1823260-2017-02083
MDR Report Key6893024
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2017-09-26
Date of Report2017-09-28
Date of Event2017-08-24
Date Mfgr Received2017-09-05
Date Added to Maude2017-09-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
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 INSTRUMENT CENTER AG TEGIMENTA
Manufacturer StreetFORRENSTRASSE NA
Manufacturer CityROTKREUZ 6343
Manufacturer CountrySZ
Manufacturer Postal Code6343
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Sequence Number: 0

Brand NameCOBAS INTEGRA 400 PLUS
Generic NameCLINICAL CHEMISTRY ANALYZER
Product CodeDIC
Date Received2017-09-26
Model NumberI400+
Catalog Number03245233001
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No0
Device Event Key0
ManufacturerROCHE DIAGNOSTICS
Manufacturer Address9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457

Device Sequence Number: 1

Brand NameCOBAS INTEGRA 400 PLUS
Generic NameCLINICAL CHEMISTRY ANALYZER
Product CodeJJE
Date Received2017-09-26
Model NumberI400+
Catalog Number03245233001
Lot NumberNA
ID NumberNA
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 2017-09-26

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.