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 2018-04-18 for TRIAGE CARDIAC PANEL KIT 97000HSEU manufactured by Quidel Cardiovascular, Inc..
[105898996]
Investigation conclusion: the customer's complaint was not replicated with in-house testing of retain lot w63541rb. No issues with ckmb recovery were observed. Manufacturing batch records for lot w63541rb were reviewed and found that the lot met final 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 (97000hseu) is not approved in the united states, this event is being reported as the device is same/similar to catalog number 97000hs, 510(k) number k030286.
Patient Sequence No: 1, Text Type: N, H10
[105898997]
Customer alleged their latest box of triage cardiac lot w63451rb was giving elevated results for ckmb while myo and tni were less than the reference value. The customer provided results of 5. 8ng/ml, 5. 9ng/ml, 5. 6ng/ml, 7. 5ng/ml and 4. 5ng/ml for ckmb. The customer could only provide data comparison for the result of 4. 5ng/ml. The sample when tested on an alternate triage product lot number yielded a ckmb of 3. 8ng/ml. The customer stated they do not have concerns with the alternate triage product lot. The customer stated the patients were not correlated with a mi. No additional information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013982035-2018-00009 |
| MDR Report Key | 7439653 |
| Report Source | CONSUMER,FOREIGN,HEALTH PROFE |
| Date Received | 2018-04-18 |
| Date of Report | 2018-04-18 |
| Date of Event | 2018-03-19 |
| Date Mfgr Received | 2018-03-20 |
| Device Manufacturer Date | 2017-09-05 |
| Date Added to Maude | 2018-04-18 |
| 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 PANEL KIT |
| Generic Name | TRIAGE CARDAIC PANEL |
| Product Code | JHX |
| Date Received | 2018-04-18 |
| Model Number | 97000HSEU |
| Lot Number | W63541RB |
| Device Expiration Date | 2018-05-19 |
| 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 | 2018-04-18 |