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 2019-03-01 for EPOC BLOOD ANALYSIS SYSTEM 10736401 manufactured by Epocal Inc..
[139209012]
The customer stated that repeat testing was performed to confirm correct results which met the clinical picture. Siemens reviewed the in-house performance of the card lot and was found to be acceptable. The customer is advised to conduct a method comparison between epoc and the non-siemens lab instruments. As per the epoc user manual section 12. 13. 7 d, "blood samples must be well mixed in order to obtain accurate hematocrit results". The cause of this event is unknown.
Patient Sequence No: 1, Text Type: N, H10
[139209013]
The customer reported discrepant hemoglobin results on the epoc blood analysis system when compared to two non-siemens hematology lab analyzers. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002637618-2019-00025 |
| MDR Report Key | 8384067 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-03-01 |
| Date of Report | 2019-03-01 |
| Date of Event | 2018-12-04 |
| Date Mfgr Received | 2019-02-02 |
| Date Added to Maude | 2019-03-01 |
| 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 | TIM KRAUSKOPF |
| Manufacturer Street | 2 EDGEWATER DRIVE |
| Manufacturer City | NORWOOD MA 02062 |
| Manufacturer Country | US |
| Manufacturer Postal | 02062 |
| Manufacturer Phone | 8622285388 |
| Manufacturer G1 | EPOCAL INC. |
| Manufacturer Street | 2060 WALKLEY ROAD |
| Manufacturer City | OTTAWA, 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 BLOOD ANALYSIS SYSTEM |
| Generic Name | EPOC |
| Product Code | CDS |
| Date Received | 2019-03-01 |
| Catalog Number | 10736401 |
| 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, K1G 3P5 CA K1G 3P5 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-01 |