MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-02-12 for EPOC READER 10736398 manufactured by Epocal Inc..
[179507423]
The customer stated that repeat testing was performed to confirm correct results which met the clinical picture and a corrected report was issued. The cause of the glucose discrepancy is unknown and will be investigated. A review of the in-house performance of the card lot in use, lot 10-19289-20, will be reviewed. The system is operational and is in use by the customer.
Patient Sequence No: 1, Text Type: N, H10
[179507424]
The customer reported discrepant glucose results on the epoc reader when compared to a non-siemens blood glucose meter. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002637618-2020-00003 |
| MDR Report Key | 9700546 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-02-12 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-01-26 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2020-02-12 |
| 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 | FELIX AKINRINOLA |
| Manufacturer Street | 2 EDGEWATER DRIVE |
| Manufacturer City | NORWOOD, MA |
| Manufacturer Country | US |
| Manufacturer Phone | 7052212 |
| Manufacturer G1 | EPOCAL INC. |
| Manufacturer Street | 2060 WALKLEY ROAD |
| Manufacturer City | OTTAWA, ONTARIO K1G 3P5 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | K1G 3P5 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EPOC READER |
| Generic Name | EPOC READER |
| Product Code | CGL |
| Date Received | 2020-02-12 |
| Catalog Number | 10736398 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EPOCAL INC. |
| Manufacturer Address | 2060 WALKLEY ROAD OTTAWA, ONTARIO K1G 3P5 CA K1G 3P5 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-12 |