MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-07-10 for I-STAT CHEM 8+ CARTRIDGE 03M88-01 manufactured by Abbott Point Of Care Canada Ltd..
[20837824]
On (b)(6) 2009, abbott point of acre was contacted by a customer who reported that an i-stat chem 8+ cartridge yielded a hematocrit result of 28% pcv. The sample (unk if the same sample) using a laboratory system yielded a hematocrit result of 23% pcv. There was a delay (time frame unk) on the transfusion to the patient. There is not indication of the i-stat chem 8+ cartridge malfunctioning. Additional information has been requested from the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2245578-2009-00018 |
| MDR Report Key | 1421676 |
| Report Source | 05 |
| Date Received | 2009-07-10 |
| Date of Report | 2009-07-10 |
| Date of Event | 2009-06-12 |
| Date Mfgr Received | 2009-06-12 |
| Device Manufacturer Date | 2009-03-01 |
| Date Added to Maude | 2011-03-23 |
| 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 INC. |
| 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 | GKF |
| Date Received | 2009-07-10 |
| Catalog Number | 03M88-01 |
| Lot Number | P09063A |
| Device Expiration Date | 2009-08-28 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 1. Other | 2009-07-10 |