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..
[90336370]
Investigation conclusion: in-house testing was performed with retains of device lot w62926b; highly elevated d-dimer results were obtained with the customer's returned sample. However, testing with whole blood specimens from in-house donors found no issues with product performance. All replicates for a given donor were consistent with one another and no discrepant results were observed. Sample-specific factors in the returned sample cannot be ruled out as the cause of the complaint. 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
[90336411]
On (b)(6) 2017, the patient arrived at the facility feeling poorly and experiencing shortness of breath and chest pressure. The patient was admitted to the emergency department. At 10:15am, a whole blood edta sample was drawn and at 11:16am the triage d-dimer panel produced an abnormal d-dimer result of 1800 ng/ml. The following day, (b)(6) 2017, repeat testing was performed with the same sample and at 11:00am the triage d-dimer panel produced an abnormal d-dimer result of 1790 ng/ml. During the hospitalization, an ekg was performed due to the chest pain and was reported to be negative. The following other cardiac marker results were also received during the hospitalization: troponin= <0. 05 ng/ml and bnp= 3670 pg/ml (method not specified). The discharge diagnosis for the patient was reported to be chest pain. The facility's triage d-dimer cutoff was provided as >500 ng/ml.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2017-00155 |
| MDR Report Key | 6946998 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2017-10-12 |
| Date of Report | 2017-09-26 |
| Date of Event | 2017-09-21 |
| Date Mfgr Received | 2017-09-26 |
| 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 |