MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-11-24 for ALERE DLM PLATFORM DLM 110, DLMGA0013992K * manufactured by Alere Medical, Inc..
[340210]
Reporter reported the electronic scale that is the essential part of the daylink monitor device was not accurate. They stated the scale was off by 11 lbs when used against their home scale which they calibrated by using a 5 lb. Bag of sugar. Reporter stated they reported this discrepancy to the manufacturing company. Reporter was returning the device to the company. Reporter concern was the wrong daily weight entered into the system by the daylink monitoring scale could result in the wrong info given to the doctor, who in turn, could prescribe the wrong follow-up treatment such as an increase in diuretics which could cause serious consequences when not needed. Pt suffers with chronic heart disease.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4003621 |
| MDR Report Key | 500422 |
| Date Received | 2003-11-24 |
| Date of Report | 2003-09-22 |
| Date Added to Maude | 2003-12-15 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALERE |
| Generic Name | DAYLINK MONITOR |
| Product Code | FRI |
| Date Received | 2003-11-24 |
| Model Number | DLM PLATFORM DLM 110, DLMGA0013992K |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 489189 |
| Manufacturer | ALERE MEDICAL, INC. |
| Manufacturer Address | 595 DOUBLE EAGLE COURT SUITE 1000 RENO NV 895212986 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-11-24 |