MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-04-26 for N/A KETONE STRIPS NA manufactured by Trividia Health, Inc..
[145240570]
(manufacturer narrative = t, corrected data = f) internal report # (b)(4). Product was returned and evaluated with no defect found. Most likely underlying root cause mlc-20 user's test strip had poor storage. Note: manufacturer contacted customer (several attempts) in a follow-up call to ensure that the replacement products resolved the initial concern - unable to establish contact at this time.
Patient Sequence No: 1, Text Type: N, H10
[145240571]
Customer reported complaint for physical defect of ketone strips. The customer stated when he removed some of the strips from the vial, the pad was falling off of the strip. Customer also stated while urinating on the pad on some of some of the strips, the pad is falling off. The customer did not report any symptoms or medical attention. The product is not stored according to specification and is stored in the bathroom. The ketone test strip lot manufacturer's expiration date is 06/25/2020 and open vial date is 03/31/2019. Customer stated the bottle had been sealed before opening.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000113657-2019-00402 |
| MDR Report Key | 8558067 |
| Report Source | CONSUMER |
| Date Received | 2019-04-26 |
| Date of Report | 2019-04-26 |
| Date of Event | 2019-04-03 |
| Date Mfgr Received | 2019-04-03 |
| Date Added to Maude | 2019-04-26 |
| 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 | 2019-04-26 |
| Returned To Mfg | 2019-04-09 |
| Model Number | KETONE STRIPS |
| Catalog Number | NA |
| Lot Number | AV460 |
| 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 | 2019-04-26 |