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 2017-12-15 for TRIAGE D-DIMER PANEL 98100EU manufactured by Quidel Cardiovascular Inc..
[95733642]
Customer's complaint was not replicated with in-house testing of retain lot w62880rb. No issues with analye recovery were observed and the product performed as expected. Manufacturing batch records were reviewed and found that the lot met release specifications. Based on the information available, there is no indicatoin of a product deficiency and no corrective action is required.
Patient Sequence No: 1, Text Type: N, H10
[95733643]
The customer provided information regarding the following event occurring on one patient: patient a (all results on same patient same day and collection time, only difference is that pathcare does d-dimer on the green top tube heparinised blood) maxi medical lab triage d-dimer - 875ng/ml (reference range < 500ng/ml) pathcare d-dimer result - 0. 42ug/ml (reference range < 0. 5 ug/ml) customer did not know the methodology performed at pathcare site. There are no clinical details available for the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024674-2017-00007 |
| MDR Report Key | 7121925 |
| Report Source | CONSUMER,FOREIGN,HEALTH PROFE |
| Date Received | 2017-12-15 |
| Date of Report | 2017-12-15 |
| Date of Event | 2017-11-10 |
| Date Mfgr Received | 2017-11-17 |
| Date Added to Maude | 2017-12-15 |
| 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 |
| Manufacturer G1 | QUIDEL CARDIOVASCULAR INC. |
| Manufacturer Street | 9975 SUMMERS RIDGE ROAD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIAGE D-DIMER PANEL |
| Generic Name | FIBRIN SPLIT PRODUCTS, PRODUCT CODE: GHH |
| Product Code | GHH |
| Date Received | 2017-12-15 |
| Model Number | 98100EU |
| Lot Number | W62880RB |
| Device Expiration Date | 2017-11-27 |
| 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 | 2017-12-15 |