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 2018-05-14 for TRIAGE D-DIMER PANEL 98100 manufactured by Quidel Cardiovascular, Inc..
[108727085]
Investigation conclusion: customers complaint was not replicated with in-house testing of retain lot w63227b. No issues with analyte recovery were observed and the product performed as expected. Manufacturing batch records for the lot were reviewed and found that the lot met 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
[108727086]
The customer alleged a variance between the triage d-dimer panel and stago satelite analyzer. Results for one patient are as follows: triage d-dimer : 446ng/ml. Stago d-dimer : 0. 67ug/ml. Cutoffs: triage=500 ng/ml ; stago=0. 5 ug/ml. The triage d-dimer result was within customers normal range for d-dimer and stago result was abnormal. Customer stated patient was only treated on stago result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013982035-2018-00013 |
| MDR Report Key | 7513159 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2018-05-14 |
| Date of Report | 2018-05-14 |
| Date Mfgr Received | 2018-04-17 |
| Device Manufacturer Date | 2017-08-07 |
| Date Added to Maude | 2018-05-14 |
| 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 | FIBRIN SPLIT PRODUCTS |
| Product Code | GHH |
| Date Received | 2018-05-14 |
| Model Number | 98100 |
| Lot Number | W63227B |
| Device Expiration Date | 2018-05-21 |
| 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 | 2018-05-14 |