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 2017-09-01 for TRIAGE D-DIMER PANEL 98100 manufactured by Alere San Diego, Inc..
[86574165]
Investigation conclusion: customer's complaint was not replicated with in-house testing of retain lot w62173b. No issues with analyte recovery were observed and the product performed as expected. 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
[86574166]
The customer reported performing a d-dimer method comparison using the triage system and the acl elite between (b)(6) 2016 and (b)(6) 2017. On (b)(6) 2017, the customer reported that the one of the physicians at the facility was concerned with the results from the method comparison. All results were obtained using patient samples. Dates and results are included below: sample number - date - triage d-dimer result - acl elite d-dimer result:(b)(6). The customer was unable to provide the normal d-dimer cutoff used for either test. The triage d-dimer panel had not been implemented at the facility for patient care.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2017-00140 |
| MDR Report Key | 6839535 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2017-09-01 |
| Date of Report | 2017-08-15 |
| Date Mfgr Received | 2017-08-15 |
| Date Added to Maude | 2017-09-01 |
| 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 | 2017-09-01 |
| Model Number | 98100 |
| Lot Number | W62173B |
| 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 | 2017-09-01 |