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 2018-08-17 for TRIAGE D-DIMER PANEL 98100EU manufactured by Quidel Cardiovascular, Inc..
[117708070]
Investigation conclusion: the customer's complaint was not replicated during in-house testing with retains of device lot w63286rb. 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. Although this catalog number (98100eu) is not approved in the united states, this event is being reported as the device is same/similar to catalog number 98100, 510(k) number k042890.
Patient Sequence No: 1, Text Type: N, H10
[117708071]
The customer reported discordant d-dimer results for one patient in the hospital. On (b)(6) 2018 the patient yielded a triage d-dimer of 1660 ng/ml, customer using a cut-off of 600 ng/ml. The patient sample was sent to another lab and tested for d-dimer using nyocard. D-dimer was 0. 3 mg/l, customer using a cut-off of 0. 3 mg/l. On (b)(6) 2018 the customer retested the patient sample on triage; d-dimer was 1720 ng/ml. Patient was diagnosed with vasovagal syncope. Patient was not diagnosed with deep vein thrombosis or pulmonary embolism.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013982035-2018-00023 |
| MDR Report Key | 7794810 |
| Report Source | CONSUMER,FOREIGN,HEALTH PROFE |
| Date Received | 2018-08-17 |
| Date of Report | 2018-08-17 |
| Date of Event | 2018-07-20 |
| Date Mfgr Received | 2018-07-21 |
| Device Manufacturer Date | 2017-11-08 |
| Date Added to Maude | 2018-08-17 |
| 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 | 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 | 2018-08-17 |
| Model Number | 98100EU |
| Lot Number | W63286RB |
| Device Expiration Date | 2018-08-22 |
| 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 | 2018-08-17 |