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 2017-01-25 for TRIAGE PROFILER SOB PANEL 97300EU manufactured by Alere San Diego, Inc..
[65773405]
Customer's complaint was not replicated with in-house testing of retain lot w62214. No issues with d-dimer recovery were observed. Manufacturing batch records for lot w62214 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. Although this catalog number (97300eu) is not approved in the united states, this event is being reported as the device is same/similar to catalog number 97300, 510(k) number k080269.
Patient Sequence No: 1, Text Type: N, H10
[65773406]
The customer porvided the following events occurring on (b)(6) 2017. Patient presented with mid thoracic back pain that was worse on inspiration. No calf tenderness or swelling. Occurred three days after air travel. Triage d-dimer result of less than 100 ng/ml. Facility unable to provide triage d-dimer cutoff but customer stated this was a normal result. Four and a half hours later, siemens innovance d-dimer result of 950 ng/ml (1. 9mg/l feu = 950 ng/ml ddu). Facility siemens d-dimer cutoff is less than 0. 5 mg/l. No information on treatment or intervention available. No additional information available.
Patient Sequence No: 1, Text Type: D, B5
[75235795]
Corrections: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2017-00023 |
| MDR Report Key | 6278084 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2017-01-25 |
| Date of Report | 2017-01-17 |
| Date of Event | 2017-01-17 |
| Date Mfgr Received | 2017-01-17 |
| Date Added to Maude | 2017-01-25 |
| 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 PROFILER SOB PANEL |
| Generic Name | CARDIOPROFILER PANEL |
| Product Code | DAP |
| Date Received | 2017-01-25 |
| Catalog Number | 97300EU |
| Lot Number | W62214 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-01-25 |