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 2019-05-07 for TRIAGE D-DIMER PANEL 98100EU manufactured by Quidel Cardiovascular Inc..
[146361553]
Investigation conclusion: the customer's complaint was not replicated during in-house testing with retains of device lot t10021rn. D-dimer recovery were observed, lot performed properly. Manufacturing batch records for the lot were reviewed, lot met 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 (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
[146361554]
Event occurred in the (b)(6). Customer reported a correlation/instrument issue with triage d-dimer cut off points compared to the lab's cut off point. Patient 1: (b)(6) male. Draw time of 9:35 on (b)(6) 2019. Time of analysis is 12:53. D-dimer results were lab analyzer=305 ng/ml and triage= 239 ng/ml. Lab analyzer cutoff- 230 ng/ml. Triage cut-off 600 ng/ml testing was performed for a d-dimer comparison study. Unknown patient outcome, no treatment was given to the patient based on the triage results. No ae.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013982035-2019-00008 |
| MDR Report Key | 8586888 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2019-05-07 |
| Date of Report | 2019-05-07 |
| Date of Event | 2019-04-08 |
| Date Mfgr Received | 2019-04-11 |
| Device Manufacturer Date | 2018-11-04 |
| Date Added to Maude | 2019-05-07 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 8583020297 |
| 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 | 2019-05-07 |
| Model Number | 98100EU |
| Lot Number | T10021RN |
| Device Expiration Date | 2019-08-18 |
| 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 | 2019-05-07 |