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 2018-07-21 for TRIAGE CARDIAC TRIPLE MARKER PANEL 97000HS manufactured by Quidel Cardiovascular, Inc..
[114684848]
Investigation pending.
Patient Sequence No: 1, Text Type: N, H10
[114684849]
The customer reported discordant ck-mb results for a patient presenting with chest pain and shortness of breath. Patients whole blood sample was tested on triage cardiac lot w63734b, results were: ck-mb=7. 5ng/ml, myo=168ng/ml, tni=<0. 05ng/ml. Patient was sent to hospital. Patient was re-drawn at the hospital 3 hours after the triage result on the roche cobas, ck-mb = 2. 9ng/ml triage ck-mb cut-off: 4. 3ng/ml. Customer did not know the roche cobas cut-off. Customer did not know patient diagnosis but stated the patient was sent home. Customer confirmed patient was not treated on triage result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013982035-2018-00019 |
| MDR Report Key | 7708984 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2018-07-21 |
| Date of Report | 2018-09-17 |
| Date of Event | 2018-06-20 |
| Date Mfgr Received | 2018-09-05 |
| Device Manufacturer Date | 2018-01-29 |
| Date Added to Maude | 2018-07-21 |
| 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 CARDIAC TRIPLE MARKER PANEL |
| Generic Name | TRIAGE CARDIAC TRIPLE MARKER PANEL |
| Product Code | JHX |
| Date Received | 2018-07-21 |
| Model Number | 97000HS |
| Lot Number | W63734B |
| Device Expiration Date | 2018-10-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-07-21 |