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..
[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
Report Number | 2028008-1997-00001 |
MDR Report Key | 136092 |
Report Source | 05 |
Date Received | 1997-12-05 |
Date of Report | 1997-12-04 |
Date of Event | 1997-11-12 |
Date Facility Aware | 1997-11-12 |
Report Date | 1997-12-04 |
Date Mfgr Received | 1997-12-04 |
Date Added to Maude | 1997-12-08 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 0 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | GLUCOSE SENSOR |
Generic Name | GLUCOSE SENSOR |
Product Code | LZF |
Date Received | 1997-12-05 |
Model Number | GLU1A |
Catalog Number | 301607 |
Lot Number | UNK |
ID Number | * |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Implant Flag | N |
Date Removed | A |
Device Sequence No | 1 |
Device Event Key | 132949 |
Manufacturer | VIA MEDICAL CORP. |
Manufacturer Address | 11425 SORRENTO VALLEY RD. SAN DIEGO CA 92121 US |
Baseline Brand Name | GLUCOSE SENSOR |
Baseline Generic Name | GLUCOSE SENSOR |
Baseline Model No | GLU1A |
Baseline Catalog No | 301607 |
Baseline ID | * |
Baseline Device Family | GLUCOSE |
Baseline Shelf Life Contained | Y |
Baseline Shelf Life [Months] | 6 |
Baseline PMA Flag | N |
Baseline 510K PMN | Y |
Premarket Notification | K951739 |
Baseline Preamendment | N |
Baseline Transitional | N |
510k Exempt | N |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Death; 2. Required No Informationntervention | 1997-12-05 |