MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-11-24 for MINIMED 511 * manufactured by Medtronic Minimed.
[22189069]
Complainant reported that their family member has been having a problem associated with their insulin pump. Pt has been wearing a pump for the last 4 to 5 years. They have been experiencing failure of the new pump three times which causes their blood sugar to severely elevate above the normal range of 100 to 120. Their blood sugar reading when they discovered the problem was near 500. The pump gives an error 21 message and erases the basal rate settings. Each time this happens, the complainant is directed by the manufacturer to replace the batteries specifically with an energizer battery. The company sent a new pump by overnight mail. A third incident happened, with the new pump sent from the company in september 2003. Pt called the customer service department and was told that the company was aware of the problem and considered this to be a "nuisance" problem and not taken as critical.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4003626 |
| MDR Report Key | 500454 |
| Date Received | 2003-11-24 |
| Date of Report | 2003-10-29 |
| Date of Event | 2003-09-15 |
| 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 | MINIMED |
| Generic Name | INSULIN PUMP |
| Product Code | LZB |
| Date Received | 2003-11-24 |
| Model Number | 511 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 489221 |
| Manufacturer | MEDTRONIC MINIMED |
| Manufacturer Address | 18000 DEVONSHIRE STREET NORTHRIDGE CA 913251219 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-11-24 |