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 2020-03-12 for EPOC HOST 2 MOTOROLA 10736387 manufactured by Epocal Inc..
[183179174]
Siemens has requested additional information several times to properly assess this event but to date it has not been provided. The data files have been received for investigation. The customer stated the qc was performing as expected at the time of the event. Twenty cards of lot 01-19291-20 were tested in the epocal r&d lab. All twenty cards reported na+ and k+ results within expected correlation to abl. No sample delivery errors were observed. Siemens investigators also reviewed the lab results. Both na+ and k+ are acceptable on the in-house tests and well centered within the post drift and delta drift limits. Approximately 11,950 cards were released from lot 01-19291-20. There have been no other complaints. The cause of this issue is unknown.
Patient Sequence No: 1, Text Type: N, H10
[183179176]
The customer reported that the epoc host/reader did not provide sample results for approximately five days on a critically ill patient. The patient is diseased. The system appears to be working as intended by giving error messages to indicate no results could be reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002637618-2020-00010 |
| MDR Report Key | 9826159 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-02-16 |
| Date Mfgr Received | 2020-02-21 |
| Date Added to Maude | 2020-03-12 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 HOST 2 MOTOROLA |
| Generic Name | EPOC HOST |
| Product Code | CGL |
| Date Received | 2020-03-12 |
| Catalog Number | 10736387 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2020-03-12 |