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 |