MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-01-10 for HEMOCUE HB 201 DM SYSTEM manufactured by Hemocue Ab.
[132786435]
Hemocue (b)(4) received a complaint stating that the customer wrongly used a blood sugar poct machine, glucose 201 dm analyzer, to check the hb value during surgery due to a mix-up of the two types of analyzers (glucose 201 dm and hb 201 dm). Consequently the anaesthetist requested (and patient was administered) 2 units of o negative blood as the result on the machine said 5. 9. The patient was unnecessarily administered 2 units of o negative blood during surgery and later 2 units of ffp was given on clinical grounds.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003044483-2019-00005 |
| MDR Report Key | 8235579 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-01-10 |
| Date of Report | 2019-02-22 |
| Date of Event | 2018-12-12 |
| Date Mfgr Received | 2019-02-04 |
| Date Added to Maude | 2019-01-10 |
| 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 | KUVETTGATAN 1 |
| Manufacturer City | 26271 |
| Manufacturer Country | SW |
| Manufacturer Postal | 26271 |
| Manufacturer G1 | HEMOCUE AB |
| Manufacturer Street | KUVETTGATAN 1 |
| Manufacturer City | 26271 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 26271 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMOCUE HB 201 DM SYSTEM |
| Generic Name | HEMOGLOBIN TEST SYSTEM |
| Product Code | GKR |
| Date Received | 2019-01-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HEMOCUE AB |
| Manufacturer Address | KUVETTGATAN 1 ?NGELHOLM, SK?NE 26271 SW 26271 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-10 |