MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-03-05 for I-STAT EG7+ CARTRIDGE 06F01-01 manufactured by Abbott Point Of Care Canada Ltd..
[1061304]
On (b) (6) 2009, abbott point of care was contacted by a customer who reported an i-stat eg7+ cartridge fielded a hematocrit result of 19%. The same sample tested using a laboratory system yielded a hematocrit result of 23%. The pt was given a transfusion (packed red blood cells) based on the i-stat result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2245578-2009-00005 |
| MDR Report Key | 1345040 |
| Report Source | 05 |
| Date Received | 2009-03-05 |
| Date of Report | 2009-03-05 |
| Date of Event | 2009-02-16 |
| Date Mfgr Received | 2009-02-16 |
| Device Manufacturer Date | 2008-11-01 |
| Date Added to Maude | 2010-01-27 |
| 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 | PETER SCOTT |
| Manufacturer Street | 400 COLLEGE RD. |
| Manufacturer City | PRINCETON NJ 08540 |
| Manufacturer Country | US |
| Manufacturer Postal | 08540 |
| Manufacturer Phone | 6094549270 |
| Manufacturer G1 | ABBOTT POINT OF CARE CANADA LTD. |
| Manufacturer Street | 185 CORKSTOWN RD. |
| Manufacturer City | OTTAWA, ONTARIO K2H8V4 |
| Manufacturer Postal Code | K2H 8V4 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | I-STAT EG7+ CARTRIDGE |
| Generic Name | EG7+ CARTRIDGE |
| Product Code | GKF |
| Date Received | 2009-03-05 |
| Model Number | NA |
| Catalog Number | 06F01-01 |
| Lot Number | P08326A |
| Device Expiration Date | 2009-07-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT POINT OF CARE CANADA LTD. |
| Manufacturer Address | OTTAWA, ONTARIO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-03-05 |