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+ CARTRIDGE 03P91-25 manufactured by Abbott Point Of Care Canada Ltd.
[1754745]
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 46%pcv. The same sample, tested using a laboratory instrument yielded a hematocrit result of 24%pcv. A second sample was tested on the i-stat and laboratory instrument, were consistent with the laboratory hematocrit result of 24%pcv.
Patient Sequence No: 1, Text Type: D, B5
[8916732]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2245578-2010-00144 |
| MDR Report Key | 1893951 |
| Report Source | 05 |
| Date Received | 2010-11-03 |
| Date of Report | 2010-11-03 |
| Date of Event | 2010-10-11 |
| Date Mfgr Received | 2010-10-11 |
| Device Manufacturer Date | 2010-08-01 |
| Date Added to Maude | 2011-02-04 |
| 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 |
| 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+ CARTRIDGE |
| Generic Name | CHEM 8+ CARTRIDGE |
| Product Code | JPI |
| Date Received | 2010-11-03 |
| Catalog Number | 03P91-25 |
| Lot Number | C10229 |
| Device Expiration Date | 2011-01-28 |
| 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 |