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 2018-05-11 for TRIAGE D-DIMER PANEL 98100EU manufactured by Quidel Cardiovascular, Inc..
[108160841]
Investigation pending. Although this catalog number (98100eu) is not approved in the united states, this event is being reported as the device is same/similar to catalog number 98100, 510(k) number k042890.
Patient Sequence No: 1, Text Type: N, H10
[108160842]
Customer reported multiple discrepant results on the triage d-dimer panel with one patient. Customer stated they tested the patient on triage meterpro s/n (b)(4) and obtained results around 300-400ng/ml for d-dimer but on a second triage instrument (serial number not provided) obtained results around 800ng/ml. The patient sample was then sent to the laboratory and was confirmed to be around 800 ng/ml. Although requested, no additional information was provided by the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013982035-2018-00012 |
| MDR Report Key | 7507654 |
| Report Source | CONSUMER,FOREIGN,HEALTH PROFE |
| Date Received | 2018-05-11 |
| Date of Report | 2018-06-14 |
| Date Mfgr Received | 2018-06-07 |
| Device Manufacturer Date | 2017-10-09 |
| Date Added to Maude | 2018-05-11 |
| 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 D-DIMER PANEL |
| Generic Name | TRIAGE D-DIMER PANEL |
| Product Code | GHH |
| Date Received | 2018-05-11 |
| Model Number | 98100EU |
| Lot Number | W63282RB |
| Device Expiration Date | 2018-07-23 |
| 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 | 2018-05-11 |