MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-09-12 for NOVA STATSTRIP AS2001 46827 manufactured by Nova Biomedical Corp..
[15805686]
An assessment was done of meters throughout the facility. It was noted that 14 of the 27 meters had batteries that were bulging and would not allow the door to close properly on the meter. A nova clinical specialist helped the facility identify this problem. All of the batteries are supplied through nova biomedical, however, they are manufactured by formosa electronic industries, inc. (rechargeable li-polymer battery pack, dc 3. 7v). Also, the facility uses another battery manufactured by a&s energy co. , ltd. (model as2001, dc 3. 7v, expiration date 11/13) however these batteries do not bulge at all. When the meters were first implemented in spring of 2013, nova did not inform the facility that there had been problems with the batteries and that the batteries have expiration dates. Also of note is that the meters with swollen batteries show the lights on the right side of the docking station to be amber in color.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3424231 |
| MDR Report Key | 3424231 |
| Date Received | 2013-09-12 |
| Date of Report | 2013-09-12 |
| Date of Event | 2013-08-22 |
| Report Date | 2013-09-12 |
| Date Reported to FDA | 2013-09-12 |
| Date Reported to Mfgr | 2013-10-23 |
| Date Added to Maude | 2013-10-23 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOVA STATSTRIP |
| Generic Name | GLUCOSE METER, BATTERY |
| Product Code | FCO |
| Date Received | 2013-09-12 |
| Model Number | AS2001 |
| Catalog Number | 46827 |
| Lot Number | * |
| ID Number | * |
| Device Availability | R |
| Device Age | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOVA BIOMEDICAL CORP. |
| Manufacturer Address | 200 PROSPECT STREET WALTHAM, MA 02454914 US 02454 9141 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-12 |