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 2018-01-19 for TRIAGE PROFILER SOB PANEL (25T) 97300EU manufactured by Quidel Cardiovascular Inc..
[97848695]
The customer's complaint was not replicated with in-house testing of retain lot w63103b. No measurement failures were observed and the product performed as expected. Manufacturing batch records for lot w63103b were reviewed and found the lot met final release specifications and showed no measurement failures at final release. A device deficiency cannot be substantiated. 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
[97848696]
The customer reported receiving two measurement failure error messages while testing a patient sample on the triage meter sn (b)(4) and triage profiler sob panel lot number w63103b. The customer stated there was a white coating on the edta blood sample. The customer was advised to centrifuge the sample and attempt to test again using plasma. However, while the sample was in the centrifuge, the patient was rushed to the hospital with suspicion of pulmonary embolism (pe). The customer stated that the patient's symptoms became more severe while attempting to obtain valid triage results. The measurement failures may have caused a delay in patient treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013982035-2018-00002 |
| MDR Report Key | 7207472 |
| Report Source | CONSUMER,FOREIGN,HEALTH PROFE |
| Date Received | 2018-01-19 |
| Date of Report | 2018-01-19 |
| Date of Event | 2017-12-22 |
| Date Mfgr Received | 2017-12-22 |
| Date Added to Maude | 2018-01-19 |
| 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 (25T) |
| Generic Name | CARDIOPROFILER PANEL |
| Product Code | DAP |
| Date Received | 2018-01-19 |
| Model Number | 97300EU |
| Lot Number | W63103B |
| Device Expiration Date | 2018-04-12 |
| 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. Hospitalization | 2018-01-19 |