MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2015-12-21 for HEMOCUE HB 201+ SYSTEM 111718 121701 manufactured by Hemocue Ab.
[33964559]
The hemocue hb 201 + system (microcuvettes and analyzer) has been investigated at hemocue ab and no malfunction could be found, both the analyzer and the returned cuvettes are within specification upon investigation. Troubleshooting together with the customer is still ongoing.
Patient Sequence No: 1, Text Type: N, H10
[33964560]
A customer has received too low results on a blood sample with a hemocue hb 201+ system. The results obtained were in the range 15-20 g/l.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003044483-2015-00019 |
| MDR Report Key | 5313349 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2015-12-21 |
| Date of Report | 2015-12-03 |
| Date of Event | 2015-11-29 |
| Date Mfgr Received | 2015-12-03 |
| Device Manufacturer Date | 2015-08-03 |
| Date Added to Maude | 2015-12-21 |
| 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 | MS MARIA FAGERBERG |
| Manufacturer Street | P.O. BOX 1204 |
| Manufacturer City | 26223 |
| Manufacturer Country | SW |
| Manufacturer Postal | 26223 |
| Manufacturer Phone | 1481346 |
| Manufacturer G1 | HEMOCUE AB |
| Manufacturer Street | P.O. BOX 1204 |
| Manufacturer City | 26223 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 26223 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMOCUE HB 201+ SYSTEM |
| Generic Name | HEMOGLOBIN SYSTEM AUTOMATED |
| Product Code | GKR |
| Date Received | 2015-12-21 |
| Returned To Mfg | 2015-12-09 |
| Model Number | 111718 |
| Catalog Number | 121701 |
| Lot Number | 1402101 |
| Device Expiration Date | 2016-01-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HEMOCUE AB |
| Manufacturer Address | P.O. BOX 1204 ?NGELHOLM, 26223 SW 26223 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-21 |