MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-04-12 for KETONE KETONE STRIPS NA manufactured by Trividia Health, Inc..
[141774706]
(b)(4). 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 that the replacement strips are working fine.
Patient Sequence No: 1, Text Type: N, H10
[141774707]
Consumer reported complaint for ketone strips (discolored grey / color does not match chart on vial). School nurse stated the keytone test strips are not changing and stated the color is a light grey. The customer did not report any symptoms neither medical attention. The product storage location is undisclosed. The ketone test strip lot manufacturer's expiration date is 05/31/2020 and open vial date is undisclosed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000113657-2019-00317 |
| MDR Report Key | 8509340 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-04-12 |
| Date of Report | 2019-04-12 |
| Date of Event | 2019-03-05 |
| Date Mfgr Received | 2019-03-26 |
| Date Added to Maude | 2019-04-12 |
| 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 | KETONE |
| Generic Name | BLOOD GLUCOSE SYSTEM |
| Product Code | JIN |
| Date Received | 2019-04-12 |
| Returned To Mfg | 2019-03-22 |
| Model Number | KETONE STRIPS |
| Catalog Number | NA |
| Lot Number | AV454 |
| 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 | 2019-04-12 |