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 2018-08-03 for TRIAGE PROFILER SOB PANEL 97300EU manufactured by Quidel Cardiovascular, Inc..
[116067520]
Investigation conclusion: the customer's complaint was not replicated during in-house testing with retains of device lot w64169b. 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 (97300eu) is not approved in the united states, this event is being reported as the device is same/similar to catalog number 97300, 510(k) number k080269.
Patient Sequence No: 1, Text Type: N, H10
[116067521]
The customer reported discordant d-dimer results for one patient. Two samples were collected from the patient at the same time. Edta sample was ran on triage and serum sample was ran on acl top 550. Results are below: sample 1 : 477 ng/ml triage vs. 741 ng/ml lab. Sample 2: 340 ng/ml triage vs. 678 ng/ml lab. Although requested, patient outcome was not provided. Customer stated there was no delay in patient treatment and there was no patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013982035-2018-00022 |
| MDR Report Key | 7748824 |
| Report Source | CONSUMER,FOREIGN,HEALTH PROFE |
| Date Received | 2018-08-03 |
| Date of Report | 2018-08-03 |
| Date of Event | 2018-06-19 |
| Date Mfgr Received | 2018-07-05 |
| Device Manufacturer Date | 2018-02-13 |
| Date Added to Maude | 2018-08-03 |
| 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 PROFILER SOB PANEL |
| Generic Name | TRIAGE PROFILER SOB PANEL |
| Product Code | DAP |
| Date Received | 2018-08-03 |
| Model Number | 97300EU |
| Lot Number | W64169B |
| Device Expiration Date | 2018-10-27 |
| 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 | 2018-08-03 |