MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-22 for TRIAGE CARDIAC TRIPLE MARKER PANEL 97000HS manufactured by Alere San Diego, Inc..
[61062169]
Investigation conclusion: investigation pending.
Patient Sequence No: 1, Text Type: N, H10
[61062170]
Report received of discrepant low tni 2x on 1 meter/1 lot. Patient #2 triage=4. 11, vista dimension=8. 09. Controls and qcd pass. Three hours between correlations. Reference range for vista dimension: 0-0. 05. Std deviation for vista dimension: 0. 004; cv=0. 05. Testing for tni on both instruments. No specific patient information provided. No reported adverse patient sequela.
Patient Sequence No: 1, Text Type: D, B5
[65859106]
Investigation/conclusion: one low tni result was observed during in-house testing of retained device lot w62028. Although the customer's complaint was replicated, the tni total cv was found to be within the package insert claim. The meter associated with the complaint was returned for investigation. In-house testing of the returned meter did not replicate the customer's complaint. No issues were observed. Manufacturing batch records for lot w62028 were reviewed and found that the lot met release specifications. Further investigation will not be pursued as the customer's reported triage and reference results all had the same clinical outcome. Product deficiency was not established.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2016-00692 |
| MDR Report Key | 6122115 |
| Date Received | 2016-11-22 |
| Date of Report | 2016-10-25 |
| Date of Event | 2016-10-20 |
| Date Mfgr Received | 2017-01-12 |
| Date Added to Maude | 2016-11-22 |
| 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 CARDIAC TRIPLE MARKER PANEL |
| Generic Name | CARDIAC MARKER TEST |
| Product Code | NBC |
| Date Received | 2016-11-22 |
| Returned To Mfg | 2017-01-04 |
| Model Number | 97000HS |
| Lot Number | W62028B |
| 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 | 2016-11-22 |