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 2018-02-05 for TRIAGE CARDIAC TRIPLE MARKER PANEL 97000HS manufactured by Quidel Cardiovascular, Inc..
[99781222]
Investigation conclusion: the customer's complaint was not replicated with in-house testing of retain lot w63311b. No issues with myoglobin recovery were observed. Manufacturing batch records for lot w63311b 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.
Patient Sequence No: 1, Text Type: N, H10
[99781223]
Customer reported that their most recent correlation yielded higher myoglobin results on the triage system than the reference lab. 2 comparisons were provided (customer unable to provide all results): triage myo=108, lab=46 , triage myo=262, lab= 94. Customer stated samples were collected in edta tubes. Whole blood was first tested on the triage system and then the samples were spun down to plasma and tested at the lab. Customer stated no issues with patient results and that they were not questioning any patient results. Customer stated they have two triage meters on site and both meters correlated well with each other (serial numbers and results not provided) despite multiple attempts customer was unable to provide myoglobin reference ranges for the triage and the reference lab. No triage myoglobin results were used to determine patient care.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013982035-2018-00003 |
| MDR Report Key | 7243282 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2018-02-05 |
| Date of Report | 2018-02-05 |
| Date Mfgr Received | 2018-01-09 |
| Device Manufacturer Date | 2017-08-07 |
| Date Added to Maude | 2018-02-05 |
| 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 PANEL |
| Product Code | JHX |
| Date Received | 2018-02-05 |
| Model Number | 97000HS |
| Lot Number | W63311B |
| Device Expiration Date | 2018-04-21 |
| 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 | 2018-02-05 |