MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-05-13 for N/A KETONE STRIPS NA manufactured by Trividia Health, Inc..
[145385841]
(manufacturer narrative = t, corrected data = f) internal report: #(b)(4). Product not returned for evaluation. Most likely underlying root cause: mlc-61-improper use / mishandled by end user. Note: manufacturer contacted customer in a follow-up call to ensure that the replacement products resolved the initial concern - unable to establish contact at this time. Product notification letter sent to contact customer care.
Patient Sequence No: 1, Text Type: N, H10
[145385842]
Consumer reported complaint for ketone strips. The customer reported complaint for negative/ no change trace results of ketone strips. The customer stated that she has been on the keto diet for some time and that the ketone test strips do not change color. The customer did not report any symptoms or medical attention. The product is stored according to specification in the bedroom. The test strip vial has not been left open and customer is following directions for proper use. The ketone test strip lot manufacturer's expiration date is 06/26/2020 and open vial date is undisclosed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000113657-2019-00504 |
| MDR Report Key | 8604116 |
| Report Source | CONSUMER |
| Date Received | 2019-05-13 |
| Date of Report | 2019-07-16 |
| Date of Event | 2019-03-08 |
| Date Mfgr Received | 2019-04-24 |
| Date Added to Maude | 2019-05-13 |
| 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 | 2019-05-13 |
| Model Number | KETONE STRIPS |
| Catalog Number | NA |
| Lot Number | AV461 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-05-13 |