MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-04-16 for N/A KETONE STRIPS NA manufactured by Trividia Health, Inc..
[142525574]
(manufacturer narrative = t, corrected data = f) internal report # (b)(4). Product not returned for evaluation. Most likely underlying root cause: mlc-20-user's test strip had poor storage. Note 1: customer reported that has 2 different ketone strips, lot# av4333 has already been reported on mdr 1000113657-2019-00337. Internal report # (b)(4). Note 2: 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 he has not use product and he will call back if he has any questions.
Patient Sequence No: 1, Text Type: N, H10
[142525575]
Consumer reported complaint for discoloration of ketone strips (discolored grey). Dad is calling on behalf of his son. The customer is concerned with tests results from results obtained of grey discoloration of ketone strips after use. The customer did not report symptoms. Medical attention is not reported as a result. The product storage location is undisclosed. The test ketone lot manufacturer's expiration date is 01/18/2020 and open vial date is undisclosed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000113657-2019-00338 |
| MDR Report Key | 8520831 |
| Report Source | OTHER |
| Date Received | 2019-04-16 |
| Date of Report | 2019-04-16 |
| Date of Event | 2019-02-25 |
| Date Mfgr Received | 2019-04-15 |
| Date Added to Maude | 2019-04-16 |
| 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 | 2019-04-16 |
| Model Number | KETONE STRIPS |
| Catalog Number | NA |
| Lot Number | AU390 |
| Device Expiration Date | 2019-07-28 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 | 2019-04-16 |