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 2020-02-21 for EPOC READER 10736398 manufactured by Epocal Inc..
[180903193]
The customer stated that repeat testing was performed to confirm correct results and a corrected report was issued. Siemens has requested the card lot number used, needed for investigation and additional information to properly assess this event. Also stated by the customer is "no qc has been performed on epoc since 2017". The cause of this event is unknown.
Patient Sequence No: 1, Text Type: N, H10
[180903194]
The customer reported discrepant low potassium results on the epoc reader when compared to a non-siemens lab analyzer. The customer stated patient treatment was affected: potassium via central line catheter was delivered at a higher dose based on the epoc result instead of delivering a lower oral dose based on the lab results. The was no reported injury to the patient due to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002637618-2020-00005 |
| MDR Report Key | 9741007 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-02-21 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-02-03 |
| Date Mfgr Received | 2020-03-20 |
| Date Added to Maude | 2020-02-21 |
| 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 |
| Product Code | CGL |
| Date Received | 2020-02-21 |
| 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 | 2020-02-21 |