MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-09-11 for I-STAT CREA CARTRIDGE 03P84-25 manufactured by Abbott Point Of Care.
[86701144]
Apoc incident # (b)(4). Apoc labeling will be evaluated during the investigation as pertaining to the event.
Patient Sequence No: 1, Text Type: N, H10
[86701145]
On (b)(6) 2017, abbott point of care was contacted by a customer regarding i-stat crea cartridges that yielded a suspected discrepant crea result on a patient. There was no additional patient information at the time of this report. There was no repeat on i-stat. Return product is not available for investigation. (b)(6). There are no injuries associated with this event. The investigation is underway.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2245578-2017-00287 |
MDR Report Key | 6854268 |
Report Source | HEALTH PROFESSIONAL |
Date Received | 2017-09-11 |
Date of Report | 2017-10-23 |
Date of Event | 2017-08-13 |
Date Mfgr Received | 2017-10-19 |
Device Manufacturer Date | 2017-05-13 |
Date Added to Maude | 2017-09-11 |
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 | ABBOTT POINT OF CARE CANADA LTD. |
Manufacturer Street | 185 CORKSTOWN ROAD |
Manufacturer City | OTTAWA, ONTARIO K2H 8V4 |
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 CREA CARTRIDGE |
Generic Name | CREA CARTRIDGE |
Product Code | CGL |
Date Received | 2017-09-11 |
Model Number | NA |
Catalog Number | 03P84-25 |
Lot Number | A17133 |
Device Expiration Date | 2017-10-28 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
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 | 1. Hospitalization | 2017-09-11 |