MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional, report with the FDA on 2018-12-13 for TRIAGE D-DIMER PANEL 98100 manufactured by Quidel Cardiovascular Inc..
[130479197]
Investigation pending.
Patient Sequence No: 1, Text Type: N, H10
[130479198]
Customer reported a discordant d-dimer result with 1 patient sample while running a whole blood to plasma correlation study. Triage d-dimer: whole blood: 215ng/ml; plasma: 448ng/ml. Patient sample resulted on stago with a d-dimer of 0. 62mg/ml feu. Customer stated stago results would have been what was used by the physician. Facility triage d-dimer cut-off = 400ng/ml, facility stago d-dimer cut-off = 0. 50mg/ml feu. Customer could not provide diagnosis information for the patient but stated the patient "presented with dizziness, nausea and pleurisy, anxiety and depression".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013982035-2018-00032 |
| MDR Report Key | 8162942 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2018-12-13 |
| Date of Report | 2018-12-13 |
| Date of Event | 2018-11-13 |
| Date Mfgr Received | 2018-11-14 |
| Device Manufacturer Date | 2018-06-03 |
| Date Added to Maude | 2018-12-13 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JESSICA PERROTTE |
| Manufacturer Street | 9975 SUMMERS RIDGE ROAD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8588053573 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIAGE D-DIMER PANEL |
| Generic Name | TRIAGE D-DIMER PANEL |
| Product Code | GHH |
| Date Received | 2018-12-13 |
| Model Number | 98100 |
| Catalog Number | 98100 |
| Lot Number | W64241B |
| Device Expiration Date | 2019-03-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUIDEL CARDIOVASCULAR INC. |
| Manufacturer Address | 9975 SUMMERS RIDGE ROAD SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-13 |