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 2018-08-27 for TRIAGE PROFILER SOB PANEL 97300EU manufactured by Quidel Cardiovascular, Inc..
[118406120]
Investigation conclusion: the customer's complaint was not replicated during in-house testing with retains of device lot w64210rb. 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
[118406121]
Customer called in stating they received a late delivery of triage sob devices. The product was in transit for four days. The customer was not informed of the delay in delivery until after testing was performed on a patient. Details of the patient testing are as follows: patient presented with right thorax pain (previously inpatient in urology). The patient was tested on triage and yielded a d-dimer of 1430ng/ml. In addition to the elevated d-dimer result, infection parameters were also increased with the patient (crp, leukos, and bsg). Patient was started on antibiotic therapy. A ct of the thorax and pulmonary scintigraphy was ordered for the patient. No left atrium enlargement (lae) identified. The doctor felt the increased d-dimer was due to the inflammation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013982035-2018-00024 |
| MDR Report Key | 7820858 |
| Report Source | CONSUMER,FOREIGN,HEALTH PROFE |
| Date Received | 2018-08-27 |
| Date of Report | 2018-08-27 |
| Date Mfgr Received | 2018-07-30 |
| Device Manufacturer Date | 2018-04-27 |
| Date Added to Maude | 2018-08-27 |
| 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 PROFILER SOB PANEL |
| Generic Name | TRIAGE PROFILER SOB PANEL |
| Product Code | DAP |
| Date Received | 2018-08-27 |
| Model Number | 97300EU |
| Lot Number | W64210B |
| Device Expiration Date | 2019-01-10 |
| 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 | 1. Other | 2018-08-27 |