MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-04-15 for N/A KETONE STRIPS NA manufactured by Trividia Health, Inc..
[142525726]
(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 - able to establish contact with customer who indicated that used product and is happy with replace.
Patient Sequence No: 1, Text Type: N, H10
[142525727]
Consumer reported complaint for negative/ no change trace results of ketone strips. The customer stated that her ketone test strips do not change color, the color always stays the same. The customer did not report any symptoms or medical attention. The product storage location is undisclosed. The ketone test strip lot manufacturer's expiration date is 11/30/2019 and open vial date is undisclosed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000113657-2019-00332 |
| MDR Report Key | 8514770 |
| Report Source | CONSUMER |
| Date Received | 2019-04-15 |
| Date of Report | 2019-07-16 |
| Date of Event | 2019-02-07 |
| Date Mfgr Received | 2019-03-26 |
| Date Added to Maude | 2019-04-15 |
| 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 | 2019-04-15 |
| Model Number | KETONE STRIPS |
| Catalog Number | NA |
| Lot Number | AV418 |
| Device Expiration Date | 2019-11-30 |
| 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 | 2019-04-15 |