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 2017-10-11 for TRIAGE D-DIMER PANEL 98100 manufactured by Alere San Diego, Inc..
[89236409]
Investigation pending.
Patient Sequence No: 1, Text Type: N, H10
[89236410]
On (b)(6) 2017, the patient arrived at the physician's office complaining of chest pain. Both d-dimer and tni testing was conducted on the patient. A whole-blood edta sample was collected at 4:30 pm and the triage d-dimer panel produced an abnormal d-dimer result of 1030 ng/ml d-du. The tni results are not available per customer but produced a normal result. Based on the abnormal d-dimer result, the patient was sent to the emergency room for a chest ct. The chest ct showed no evidence of pulmonary embolism and no evidence of acute cardio pulmonary disease. At the emergency room, confirmatory testing was conducted using the hemosil system and resulted in a normal d-dimer value of 300 ng/ml d-du. On (b)(6) 2017, the same whole-blood edta sample was tested an additional two times at approximately 1:00 pm. The triage d-dimer panel produced abnormal results of 968 ng/ml d-du and 825 ng/ml d-du. The facility's normal d-dimer cutoff for both the triage and hemosil systems was reported to be 400 ng/ml d-du.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2017-00153 |
| MDR Report Key | 6942683 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2017-10-11 |
| Date of Report | 2017-09-13 |
| Date of Event | 2017-09-12 |
| Date Mfgr Received | 2017-12-01 |
| Date Added to Maude | 2017-10-11 |
| 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 | 2017-10-11 |
| Returned To Mfg | 2017-11-29 |
| Model Number | 98100 |
| Lot Number | W62923B |
| Device Expiration Date | 2018-01-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 1. Other | 2017-10-11 |