MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-01-05 for TRIAGE PROFILER SOB PANEL C97300 manufactured by Alere San Diego, Inc..
[19872975]
Caller reported false negative myoglobin results. Pt died. Unable to determine cause of death; due to medical code of ethics, customer would not specify.
Patient Sequence No: 1, Text Type: D, B5
[19941844]
Investigation pending.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2011-00030 |
| MDR Report Key | 1959449 |
| Report Source | 07 |
| Date Received | 2011-01-05 |
| Date of Report | 2011-01-05 |
| Date of Event | 2010-12-15 |
| Date Mfgr Received | 2010-12-15 |
| Date Added to Maude | 2011-01-18 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CARMEN BERGELIN, MANAGER |
| Manufacturer Street | 9975 SUMMERS RIDGE RD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8588052256 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIAGE PROFILER SOB PANEL |
| Generic Name | CARDIAC MARKER TEST |
| Product Code | DDR |
| Date Received | 2011-01-05 |
| Model Number | C97300 |
| Lot Number | W47487B |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE SAN DIEGO, INC. |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2011-01-05 |