MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-08-21 for I-STAT1 ANALYZER, IMMUNO READY 06F16-10 manufactured by Abbott Point Of Care.
| Report Number | 2245578-2019-00201 |
| MDR Report Key | 8915109 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-08-21 |
| Date of Report | 2019-09-24 |
| Date of Event | 2019-08-05 |
| Date Mfgr Received | 2019-09-24 |
| Device Manufacturer Date | 2007-05-14 |
| Date Added to Maude | 2019-08-21 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | LINDA MACZUSZENKO |
| Manufacturer Street | 400 COLLEGE ROAD |
| Manufacturer City | PRINCETON NJ 08540 |
| Manufacturer Country | US |
| Manufacturer Postal | 08540 |
| Manufacturer Phone | 6136885949 |
| Manufacturer G1 | FLEXTRONICS MANUFACTURING (SINGAPORE) |
| Manufacturer Street | PTE LTD 1 KALLANG PLACE |
| Manufacturer City | 339211 |
| Manufacturer Country | SN |
| Manufacturer Postal Code | 339211 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | I-STAT1 ANALYZER, IMMUNO READY |
| Generic Name | I-STAT1 ANALYZER |
| Product Code | CGA |
| Date Received | 2019-08-21 |
| Returned To Mfg | 2019-09-04 |
| Model Number | NA |
| Catalog Number | 06F16-10 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT POINT OF CARE |
| Manufacturer Address | 400 COLLEGE ROAD PRINCETON NJ 085406607 US 085406607 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-21 |