MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-10-28 for THEO FLEX REAGENT CARTRIDGE DF71 manufactured by Dade International, Inc..
[21965149]
Hospitalized patient receiving theophylline intravenously; blood was tested for theophylline levels on dimension 380 clinical chemistry system using the theo flex (tm) reagent cartridge. Due to falsely low theo results, at 1700 the i. V. Dose was increased. Subsequently, the patient started shaking, was diaphoretic, heart rate >125, and "blood pressure was up. " the i. V. Was discontinued at 2000. Medical personnel reported the patient stabilized with "no adverse effects from the higher does of theophylline. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-1997-00001 |
| MDR Report Key | 128990 |
| Report Source | 05 |
| Date Received | 1997-10-28 |
| Date of Report | 1997-10-27 |
| Date of Event | 1997-10-01 |
| Date Mfgr Received | 1997-10-02 |
| Device Manufacturer Date | 1997-06-01 |
| Date Added to Maude | 1997-11-03 |
| 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 | 0 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THEO FLEX REAGENT CARTRIDGE |
| Generic Name | IVD-THEO TEST SYSTEM |
| Product Code | KLS |
| Date Received | 1997-10-28 |
| Model Number | NA |
| Catalog Number | DF71 |
| Lot Number | FA8156 |
| ID Number | NA |
| Device Expiration Date | 1998-06-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 126175 |
| Manufacturer | DADE INTERNATIONAL, INC. |
| Manufacturer Address | ROUTE 896 P.O. BOX 6101 NEWARK DE 19702 US |
| Baseline Brand Name | THEO FLEX REAGENT CARTRIDGE |
| Baseline Generic Name | THEOPHYLLINE TEST SYSTEM |
| Baseline Model No | NA |
| Baseline Catalog No | DF71 |
| Baseline ID | NA |
| Baseline Device Family | THEO TEST SYSTEMS |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | 12 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K862955 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 6 | 1. Required No Informationntervention | 1997-10-28 |