ROCHE 9180 ELECTROLYTE ANALYZER ISE 9180 03157334001

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 2018-08-06 for ROCHE 9180 ELECTROLYTE ANALYZER ISE 9180 03157334001 manufactured by Roche Diagnostics.

Event Text Entries

[116872936] (b)(6).
Patient Sequence No: 1, Text Type: N, H10


[116872937] The customer stated that they received an erroneous result for one patient sample tested for potassium on a roche 9180 electrolyte analyzer. The sample resulted with a potassium value of 6. 7 mmol/l when tested on the 9180. The sample was repeated on an istat analyzer, resulting as 4. 6 mmol/l. Both values were reported outside of the laboratory to the doctor. No adverse events were alleged to have occurred with the patient. The potassium electrode lot number and expiration date were asked for, but not provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1823260-2018-02623
MDR Report Key7752893
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2018-08-06
Date of Report2018-09-13
Date of Event2018-07-20
Date Mfgr Received2018-07-20
Date Added to Maude2018-08-06
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 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 Details

Brand NameROCHE 9180 ELECTROLYTE ANALYZER
Generic NameELECTROLYTE ANALYZER
Product CodeJFP
Date Received2018-08-06
Model NumberISE 9180
Catalog Number03157334001
Lot 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 2018-08-06

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