MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-04-25 for N/A KETONE STRIPS NA manufactured by Trividia Health, Inc..
[145238314]
(manufacturer narrative = t, corrected data = f) internal report: # (b)(4). Product returned for evaluation, defect found - discolored grey pads. Final root cause investigation has been completed rc-061 storage outside specifications. Note: manufacturer contacted customer in a follow-up call to ensure that the replacement products resolved the initial concern - able to establish contact with customer who indicated is comfortable with the replacement product.
Patient Sequence No: 1, Text Type: N, H10
[145238315]
Customer called in stating that the ketone strips looked discolored. No additional information was provided. No adverse event or medical intervention was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000113657-2019-00393 |
| MDR Report Key | 8553076 |
| Report Source | CONSUMER |
| Date Received | 2019-04-25 |
| Date of Report | 2019-04-25 |
| Date of Event | 2019-04-01 |
| Date Mfgr Received | 2019-04-01 |
| Date Added to Maude | 2019-04-25 |
| 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 | KAREN DEVINCENT |
| Manufacturer Street | 2400 NW 55TH COURT |
| Manufacturer City | FORT LAUDERDALE FL 33309 |
| Manufacturer Country | US |
| Manufacturer Postal | 33309 |
| Manufacturer Phone | 954677-920 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | N/A |
| Generic Name | BLOOD GLUCOSE SYSTEM |
| Product Code | JIN |
| Date Received | 2019-04-25 |
| Returned To Mfg | 2019-04-15 |
| Model Number | KETONE STRIPS |
| Catalog Number | NA |
| Lot Number | AV441 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TRIVIDIA HEALTH, INC. |
| Manufacturer Address | 2400 NW 55TH COURT FORT LAUDERDALE FL 33309 US 33309 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-25 |