MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-01-26 for INSTAREAD LITHIUM SYSTEM * manufactured by Akers Biosciences Inc.
[15214361]
Rptr purchased a clia waived instaread lithium system after reading the literature which stated the system could test lithium levels in whole blood after either fingerstick or blood from an edta tube. As a way of assuring that the test was reliable, rptr also sent samples to regular laboratory. When doing this rptr noticed that there was sometimes up to 0. 5 meq/l -higher- difference in the laboratory method, vs point-of-care test. The differences were not consistent enough that rptr could not extrapolate from this a method to "correct" for the variance.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1037847 |
| MDR Report Key | 672100 |
| Date Received | 2006-01-26 |
| Date of Report | 2006-01-26 |
| Date of Event | 2006-01-25 |
| Date Added to Maude | 2006-02-09 |
| 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 |
| 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 | INSTAREAD LITHIUM SYSTEM |
| Generic Name | * |
| Product Code | JIH |
| Date Received | 2006-01-26 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | CA142A05 |
| ID Number | 19100 -12/06-,1811 |
| Device Expiration Date | 2006-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 661424 |
| Manufacturer | AKERS BIOSCIENCES INC |
| Manufacturer Address | * THOREFARE NJ 08086 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2006-01-26 |