MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-11-03 for I-STAT CHEM 8+N CARTRIDGE 03P91-25 manufactured by Abbott Point Of Care Canada Ltd.
[20414750]
On (b)(6) 2010, abbott point of care was contacted by a customer who reported the i-stat chem 8+ cartridge yielded a hematocrit result of 37% pcv. A separate sample, drawn at the same time as the i-stat sample, was tested on the lab instrument and the hematocrit result was 15. 4% pcv. No repeat labs performed. Patient was not treated on either hematocrit result. Patient died of respiratory failure at 6:30pm (b)(6) 2010.
Patient Sequence No: 1, Text Type: D, B5
[20594953]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2245578-2010-00141 |
| MDR Report Key | 1893966 |
| Report Source | 05 |
| Date Received | 2010-11-03 |
| Date of Report | 2010-11-03 |
| Date of Event | 2010-10-11 |
| Date Mfgr Received | 2010-10-14 |
| Device Manufacturer Date | 2010-06-01 |
| Date Added to Maude | 2011-03-22 |
| 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 | 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 Country | CA |
| Manufacturer Postal Code | K2H 8V4 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | I-STAT CHEM 8+N CARTRIDGE |
| Generic Name | CHEM 8+ CARTRIDGE |
| Product Code | GKF |
| Date Received | 2010-11-03 |
| Catalog Number | 03P91-25 |
| Lot Number | G10170 |
| Device Expiration Date | 2010-12-14 |
| Device Availability | N |
| Device Age | DA |
| 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 CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-11-03 |