RAPIDPOINT 400 109824

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-03-30 for RAPIDPOINT 400 109824 manufactured by Chiron Diagnostics Corp..

Event Text Entries

[129910] Customer reported under-recovery of rapidqc complete quality control material for partial oxygen pressure results. Level 1 : assigned range 134-156 mmhg; values obtained 126/127/130 mmhg; level 2: assigned range 88-104; values obtained 83/85/97; level 3: assigned range 12-34; values obtained 21/22. This indicated that there was potential for under-reporting pt values for partial pressure of oxygen. It is believed that no pt data was reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1217157-1999-00001
MDR Report Key217100
Report Source05
Date Received1999-03-30
Date of Report1999-03-01
Date of Event1999-03-01
Date Mfgr Received1999-03-01
Date Added to Maude1999-04-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRESPIRATORY THERAPIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use3
Remedial ActionNO
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRAPIDPOINT 400
Generic NameBLOOD GAS ANALYZER
Product CodeCCC
Date Received1999-03-30
Model NumberNA
Catalog Number109824
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key210584
ManufacturerCHIRON DIAGNOSTICS CORP.
Manufacturer Address63 NORTH ST. MEDFIELD MA 020521688 US
Baseline Brand NameRAPIDPOINT 400
Baseline Generic NameBLOOD GAS ANALYZER
Baseline Model NoNA
Baseline Catalog No109824
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1999-03-30

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