N
Patient 1
APOC INCIDENT # (B)(4). APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.
MAUDE MDR 7325134
- MDR report key
- 7325134
- Report number
- 2245578-2018-00108
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-02-16
- Date received
- 2018-03-08
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- LINDA MACZUSZENKO
- Address
- 400 COLLEGE ROAD PRINCETON NJ 08540 US
- Phone
- 613-613-6136
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | I-STAT CREA CARTRIDGE | CREA CARTRIDGE | ABBOTT POINT OF CARE | CGL | NA | 03P84-25 | A18010 | Y | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-03-08 | 0 |
Event Narratives#
D
Patient 1
ON (B)(6) 2018, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT CREATININE RESULT ON A (B)(6) YEAR OLD PATIENT WITH AMS (UNK). THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. (B)(6). THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.