MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,health profe report with the FDA on 2017-07-19 for TRIAGE PROFILER SOB PANEL 25T 97300EU manufactured by Alere San Diego, Inc..
[80473857]
Investigation pending. This event is being reported as part number 97300eu is same/similar to 510 (k): k080269.
Patient Sequence No: 1, Text Type: N, H10
[80473858]
The customer reported the following events occurring on one patient. The customer reported being concerned with the d-dimer results. On (b)(6) 2017, the patient arrived to the emergency department with chest pain. An initial draw was performed and both whole blood and plasma were collected in edta: (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2017-00120 |
| MDR Report Key | 6725849 |
| Report Source | CONSUMER,FOREIGN,HEALTH PROFE |
| Date Received | 2017-07-19 |
| Date of Report | 2017-06-22 |
| Date of Event | 2017-05-15 |
| Date Mfgr Received | 2017-07-25 |
| Date Added to Maude | 2017-07-19 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | YA-LING KING |
| Manufacturer Street | 9975 SUMMERS RIDGE ROAD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8588052084 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIAGE PROFILER SOB PANEL 25T |
| Generic Name | CARDIOPROFILER PANEL |
| Product Code | DAP |
| Date Received | 2017-07-19 |
| Model Number | 97300EU |
| Lot Number | W62463B |
| 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 | 9975 SUMMERS RIDGE ROAD SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-19 |