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 2018-09-06 for TRIAGE D-DIMER PANEL 98100 manufactured by Quidel Cardiovascular Inc..
[119501744]
Investigation conclusion: the customer's complaint was not replicated during in-house testing with retains of device lot w64237b. No issues with d-dimer recovery were observed; lot performed properly. Manufacturing batch records for the lot were reviewed, lot met release specifications. Based on the information available, there is no indication of a product deficiency and no corrective action is required.
Patient Sequence No: 1, Text Type: N, H10
[119501745]
The customer reported variability between results produced on the triage d-dimer system. On (b)(6) 2018 a patient presented to the customer site with localized edema. Patient sample was tested on triage platform and produced d-dimer results of 455ng/ml, 205ng/ml, 233ng/ml, 307ng/ml and 445ng/ml. The specific time of testing was not provided but customer stated testing was all done on the same day with the same draw. Customer indicated the result of 455ng/ml was the reported result for the patient. Clinics reference range for triage d-dimer is <400ng/ml. Customer stated no other lab tests were performed and customer did not know patient diagnosis/outcome, treatment or medical history.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013982035-2018-00026 |
| MDR Report Key | 7853079 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2018-09-06 |
| Date of Report | 2018-09-06 |
| Date of Event | 2018-08-01 |
| Date Mfgr Received | 2018-08-07 |
| Device Manufacturer Date | 2018-04-28 |
| Date Added to Maude | 2018-09-06 |
| 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 | 2018-09-06 |
| Model Number | 98100 |
| Lot Number | W64237B |
| Device Expiration Date | 2019-02-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-09-06 |