GLUCOSE SENSOR GLU1A 301607

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 1997-12-05 for GLUCOSE SENSOR GLU1A 301607 manufactured by Via Medical Corp..

Event Text Entries

[100477] Via monitor that had been attached to an arterial line was disconnected and attached to the mid port of a central venous catheter line post-operatively; the proximal port (where the via should have been installed) was being used to deliver dextrose to the pt. The via monitor was indicating readings >600 mg/dl. Nurse on duty began treating from these values and gave substantial volume of insulin to reduce the glucose level. She continued this treatment for approx. 6 hrs. A blood sample was taken to the lab and indicated pt blood glucose level was 17 mg/dl the nurse making the report ( a different nurse that the one who had used the via product on the pt) indicated that the death was not a result of the mistreatment based upon the misapplication of the via monitor.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2028008-1997-00001
MDR Report Key136092
Report Source05
Date Received1997-12-05
Date of Report1997-12-04
Date of Event1997-11-12
Date Facility Aware1997-11-12
Report Date1997-12-04
Date Mfgr Received1997-12-04
Date Added to Maude1997-12-08
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGLUCOSE SENSOR
Generic NameGLUCOSE SENSOR
Product CodeLZF
Date Received1997-12-05
Model NumberGLU1A
Catalog Number301607
Lot NumberUNK
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key132949
ManufacturerVIA MEDICAL CORP.
Manufacturer Address11425 SORRENTO VALLEY RD. SAN DIEGO CA 92121 US
Baseline Brand NameGLUCOSE SENSOR
Baseline Generic NameGLUCOSE SENSOR
Baseline Model NoGLU1A
Baseline Catalog No301607
Baseline ID*
Baseline Device FamilyGLUCOSE
Baseline Shelf Life ContainedY
Baseline Shelf Life [Months]6
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK951739
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Death; 2. Required No Informationntervention 1997-12-05

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