MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2012-04-18 for TRIAGE D-DIMER TEST 98100 manufactured by Alere San Diego, Inc..
[2606306]
Customer alleges (b)(6) d-dimer results with 3 samples while running a plasma to (b)(4) study: sample number: 8310, plasma: 501, whole blood: 280. Sample number: 8325, plasma: 446, whole blood: 232, sample number: 8232, plasma: 471, whole blood: 232. Customer uses a cutoff of 400 to determine positive d-dimer results. This (b)(4) study was run using 2 triage meters. Results from the other meter (b)(4) have been reported on mdr number 2027969-2012-000535.
Patient Sequence No: 1, Text Type: D, B5
[9819143]
Investigation pending.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2012-00534 |
| MDR Report Key | 2544968 |
| Report Source | 00,05 |
| Date Received | 2012-04-18 |
| Date of Report | 2012-04-18 |
| Date of Event | 2012-03-26 |
| Date Mfgr Received | 2012-03-26 |
| Date Added to Maude | 2012-06-12 |
| 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 D-DIMER TEST |
| Generic Name | CARDIAC MARKER TEST |
| Product Code | GJA |
| Date Received | 2012-04-18 |
| Model Number | 98100 |
| Lot Number | W50551B |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2012-04-18 |