MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-23 for N/A KETONE STRIPS NA manufactured by Trividia Health, Inc..
[145113682]
(manufacturer narrative = t, corrected data = f) internal report: # (b)(4). Product was returned and evaluated - reported defect not reproduced. Most likely underlying root cause: mlc-1 user had an inaccurate reference. 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 he is comfortable with the replacement product.
Patient Sequence No: 1, Text Type: N, H10
[145113683]
Consumer reported complaint for negative/no change trace results with ketone strips. Customer stated that the color is not changing like it should, states that certain part of the pad will change color, but some does not. Some of the port of the strips will change and then some parts of the strips will stay beige. Customer test 2-3 strips as the same time and have been using these strips for some time now. The customer did not report symptoms or medical attention. The product is not stored according to specification in the bathroom. The ketone test strip lot manufacturer's expiration date is undisclosed and open vial date is undisclosed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000113657-2019-00378 |
| MDR Report Key | 8541488 |
| Date Received | 2019-04-23 |
| Date of Report | 2019-07-17 |
| Date of Event | 2019-03-27 |
| Date Mfgr Received | 2019-03-27 |
| Date Added to Maude | 2019-04-23 |
| 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 | 2019-04-23 |
| Returned To Mfg | 2019-04-05 |
| Model Number | KETONE STRIPS |
| Catalog Number | NA |
| Lot Number | AV467 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| 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 | 2019-04-23 |