MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2015-03-13 for HEMOCUE HB201+ SYSTEM 111717 121701 manufactured by Hemocue Ab.
[5761748]
A hemocue hb 201 system has provided a result that is outside spec when compared to results provided by laboratory methods. This could potentially lead to a missed clinical action if it was to recur. Hemocue: 116 g/l; lab method 1: 70 g/l; lab method 2: 72 g/l; no pt impact reported. The user did not take any action based on the result from the hemocue system.
Patient Sequence No: 1, Text Type: D, B5
[13030168]
The hemocue hb 201 microcurvettes returned by the customer from the same lot that were used at the event have been investigated at hemocue. No malfunction was detected. Note that similar events at the same hosp with the same microcurvettes have been reported previously: mdr number 300304483-2015-00002 and mdr number 300304483-2015-00003.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003044483-2015-00014 |
| MDR Report Key | 4613521 |
| Report Source | 01,05 |
| Date Received | 2015-03-13 |
| Date of Report | 2015-02-18 |
| Date of Event | 2015-02-16 |
| Date Mfgr Received | 2015-02-18 |
| Device Manufacturer Date | 2013-12-01 |
| Date Added to Maude | 2015-04-22 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARIA FAGERBERG, RA MANAGER |
| Manufacturer Street | P.O. BOX 1204 |
| Manufacturer City | ANGELHOLM SE-26223 |
| Manufacturer Country | SW |
| Manufacturer Postal | SE-26223 |
| Manufacturer Phone | 31481346 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMOCUE HB201+ SYSTEM |
| Generic Name | SYSTEM, HEMOGLOBIN, AUTOMATED |
| Product Code | GKR |
| Date Received | 2015-03-13 |
| Returned To Mfg | 2015-02-04 |
| Model Number | 111717 |
| Catalog Number | 121701 |
| Lot Number | 1406862 |
| Device Expiration Date | 2015-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HEMOCUE AB |
| Manufacturer Address | ANGELHOLM SW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-13 |