MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-04-05 for QUALICHECK, LEVEL 1 944-099 manufactured by Radiometer Medical Aps.
[3396760]
No patient was involved in this event. This event concerns a user error where a nurse hurt herself when opening a glass ampoule. The nurse did not use the recommended ampoule opener (920-712) when she opened a qualicheck level 1 ampoule. The break was uneven and left a sharp point which punctured her glove and cut her left thumb. It is recommended to use the ampoule opener when opening qualicheck ampoules. When breaking glass ampoules with the hands, there is an increased risk of hand injury. According to the safety data sheet the potential hazards of the product are considered to be limited. The product does, however, contain a small quantity of an allergenic additive which can, in disposed individuals, cause an allergic reaction. The nurse has reported that she has not experienced any ill effects from the incident. She has also now been provided with an ampoule opener for future use.
Patient Sequence No: 1, Text Type: D, B5
[10614441]
No investigation of the device in question was performed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002807968-2013-00007 |
| MDR Report Key | 3050263 |
| Report Source | 05 |
| Date Received | 2013-04-05 |
| Date of Report | 2013-03-06 |
| Date of Event | 2013-03-01 |
| Date Mfgr Received | 2013-03-06 |
| Date Added to Maude | 2013-06-04 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MAIKE DIDERIKSEN, SPECIALIST |
| Manufacturer Street | AKANDEVEJ 21 |
| Manufacturer City | BRONSHOJ DK-2700 |
| Manufacturer Country | DA |
| Manufacturer Postal | DK-2700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUALICHECK, LEVEL 1 |
| Generic Name | S7570 HIGH METABOLIC QC SOLUTION |
| Product Code | GIO |
| Date Received | 2013-04-05 |
| Catalog Number | 944-099 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RADIOMETER MEDICAL APS |
| Manufacturer Address | AKANDEVEJ 21 BRONSHOJ DK-2700 DA DK-2700 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-05 |