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 2017-03-21 for TRIAGE D-DIMER PANEL 98100 manufactured by Alere San Diego, Inc..
[70630485]
Investigation conclusion: customer's complaint was not replicated with in-house testing of retain lot w62690b. No issues with d-dimer recovery were observed. Manufacturing batch records for lot w62690b 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
[70630486]
The customer provided the following data for a correlation study using patient samples between the stago and triage systems. The stago system reports in feu while the triage system reports in ddu. The customer reported expecting the triage d-dimer results to be approximately half of the stago d-dimer results. (b)(6). Per customer, the facility stago d-dimer cutoff is 500 ng/ml feu. The facility does not have a d-dimer cutoff for the triage system. No triage d-dimer results were used to determine patient care.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2017-00048 |
| MDR Report Key | 6421965 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2017-03-21 |
| Date of Report | 2017-02-21 |
| Date of Event | 2017-02-14 |
| Date Mfgr Received | 2017-02-21 |
| Date Added to Maude | 2017-03-21 |
| 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 | YA-LING KING |
| Manufacturer Street | 9975 SUMMERS RIDGE ROAD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8588052084 |
| 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 | DAP |
| Date Received | 2017-03-21 |
| Catalog Number | 98100 |
| Lot Number | W62690B |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE SAN DIEGO, INC. |
| Manufacturer Address | 9975 SUMMERS RIDGE ROAD SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-21 |