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 2018-04-16 for TRIAGE PROFILER SOB PANEL 97300EU manufactured by Quidel Cardiovascular, Inc..
[105760339]
Investigation conclusion: the customer's complaint was not replicated with in-house testing of retain lot w63556b. No issues with tni recovery were observed. Manufacturing batch records for lot w63556b were reviewed and found that the lot met final release specifications. The customer could not provide patient diagnosis from the hospital specialized in cardiology. The only information available is patient is in good health condition. 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
[105760340]
A patient experienced respiratory distress and was tested for cardiac markers using the triage system. The triage system produced results of tni= <0. 05 ng/ml and bnp= 96 pg/ml. As the triage tni result was determined to be normal by the customer, the patient was taken to the emergency unit of a hospital instead of a hospital with a cardiology unit. The patient was tested in the emergency unit by another service an hour later and received results of tni= 0. 0792 ng/ml and bnp= 387 pg/ml (normal tni cutoff for this instrument= 0. 034 ng/ml). As this tni result was abnormal, the decision was made to transfer the patient to another hospital specialized in cardiology. The patient's diagnosis prior to transfer was heart failure and coronary distress. As of march 29, 2018, the patient is reported to be in good condition.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3013982035-2018-00008 |
MDR Report Key | 7434896 |
Report Source | CONSUMER,FOREIGN,HEALTH PROFE |
Date Received | 2018-04-16 |
Date of Report | 2018-04-16 |
Date Mfgr Received | 2018-03-19 |
Device Manufacturer Date | 2017-10-16 |
Date Added to Maude | 2018-04-16 |
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 | KIT, TRIAGE, SOB |
Product Code | DAP |
Date Received | 2018-04-16 |
Model Number | 97300EU |
Lot Number | W63566B |
Device Expiration Date | 2018-06-30 |
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 | 2018-04-16 |