MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-04-10 for I-STAT CG8+ CARTRIDGE 03M86-01 manufactured by Abbott Point Of Care Inc..
[827971]
In 2008, abbott point of care was contacted by a customer who reported that an i-stat cg8+ cartridge yielded a ionized calcium result of 1. 0 mmol/l, sample drawn at 06:12. A sample, drawn at 06:19, tested using a laboratory system yielded a result of 1. 29 mmol/l. Customer states other i-stat and laboratory results correlate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2245578-2008-00019 |
| MDR Report Key | 1028064 |
| Report Source | 05 |
| Date Received | 2008-04-10 |
| Date of Report | 2008-04-02 |
| Date of Event | 2008-03-04 |
| Date Mfgr Received | 2008-03-04 |
| Device Manufacturer Date | 2007-08-12 |
| Date Added to Maude | 2009-03-30 |
| 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 | JULIA DING |
| Manufacturer Street | 104 WINDSOR CENTER DRIVE |
| Manufacturer City | EAST WINDSOR NJ 08520 |
| Manufacturer Country | US |
| Manufacturer Postal | 08520 |
| Manufacturer Phone | 6094439300 |
| Manufacturer G1 | ABBOTT POINT OF CARE CANADA LTD. |
| Manufacturer Street | 436 HAZELDEAN ROAD |
| Manufacturer City | KANATA, ONTARIO K2L-1T9 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | K2L-1T9 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | I-STAT CG8+ CARTRIDGE |
| Generic Name | IVD |
| Product Code | JFP |
| Date Received | 2008-04-10 |
| Model Number | NA |
| Catalog Number | 03M86-01 |
| Lot Number | L07224 |
| Device Expiration Date | 2008-03-28 |
| Operator | HEALTH PROFESSIONAL |
| 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 INC. |
| Manufacturer Address | 104 WINDSOR CENTER DRIVE EAST WINDSOR NJ 08520 US 08520 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-04-10 |