MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-04-23 for N/A KETONE STRTIP NA manufactured by Trividia Health, Inc..
[142890286]
(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 customer symptoms improved and replacement products resolved the initial concern - able to establish contact with customer who indicated his symptoms improved. Customer contacted at later time to find out about replacement product - unable to establish contact at this time. Product notification letter sent to contact customer care.
Patient Sequence No: 1, Text Type: N, H10
[142890287]
Consumer reported complaint for negative/ no change trace results accompanied by symptoms. Customer just performed a test prior to calling and stated there was no changes in the ketone strips when testing. The customer did report symptoms of upset stomach, tired and lethargic. Medical attention is not reported as a result of the actual blood glucose results and reported symptoms, she will most likely contact doctor for instruction. The product storage location is undisclosed. The ketone test strip lot manufacturer's expiration date is 07/16/2020 and open vial date is (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000113657-2019-00379 |
| MDR Report Key | 8542081 |
| Report Source | CONSUMER |
| Date Received | 2019-04-23 |
| Date of Report | 2019-04-23 |
| Date of Event | 2019-03-28 |
| Date Mfgr Received | 2019-03-28 |
| 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 | 2019-04-16 |
| Model Number | KETONE STRTIP |
| Catalog Number | NA |
| Lot Number | AV466 |
| 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 | 2019-04-23 |