MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-12-09 for TRIAGE D-DIMER PANEL 98100EU manufactured by Alere San Diego, Inc..
[62376589]
Investigation conclusion: customer's complaint was not replicated with in-house testing of retain lot w62131. No issues with d-dimer recovery were observed. Manufacturing batch records for lot w62131 were reviewed and found that the lot met release specifications. Further investigation was not possible since the customer did not return any samples for testing. Unable to determine a root cause from the available information. Product deficiency was not established.
Patient Sequence No: 1, Text Type: N, H10
[62376590]
Event occurred in (b)(6). The customer reported receiving a false negative result with triage d-dimer panel from lot w62131rba. The customer received a negative result of <100. The customer tested with edta whole blood. The other gp of the patient sent a sample for confirmatory testing to a lab on the same day and they received a positive result of 694. The patient's specimen was sent to the lab in a citrate tube. There were no reported adverse events related to the triage result. No additional information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2016-00701 |
| MDR Report Key | 6159947 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-12-09 |
| Date of Report | 2016-11-30 |
| Date Mfgr Received | 2016-11-30 |
| Date Added to Maude | 2016-12-09 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | CARDIAC MARKER TEST |
| Product Code | NBC |
| Date Received | 2016-12-09 |
| Model Number | 98100EU |
| Lot Number | W62131RBA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2016-12-09 |