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 2017-10-12 for TRIAGE D-DIMER PANEL 98100 manufactured by Alere San Diego, Inc..
[90306943]
Investigation conclusion: the customer's complaint was not replicated during in-house testing with retains of device lot w62926b.?? No issues with analyte recovery were observed. 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
[90306944]
On (b)(6) 2017, the patient arrived at the facility in respiratory distress and was admitted to the emergency department. At 1:00 pm, a whole blood edta sample was drawn and at 1:58 pm the triage d-dimer panel produced an abnormal d-dimer result of 1370 ng/ml. No laboratory confirmatory testing was conducted and no other cardiac marker results were provided. The customer provided that the abnormal d-dimer result did not correlate to the patient's diagnosis. The discharge diagnosis for the patient was reported to be an unspecified respiratory disorder. The facility's triage d-dimer cutoff was provided as >500 ng/ml.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2017-00154 |
| MDR Report Key | 6946969 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2017-10-12 |
| Date of Report | 2017-09-16 |
| Date of Event | 2017-09-13 |
| Date Mfgr Received | 2017-09-16 |
| Date Added to Maude | 2017-10-12 |
| 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 | GHH |
| Date Received | 2017-10-12 |
| Model Number | 98100 |
| Lot Number | W62926B |
| Device Expiration Date | 2018-01-16 |
| 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 | 2017-10-12 |