N
Patient 1
APOC INCIDENT # (B)(4). APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.
MAUDE MDR 7311651
- MDR report key
- 7311651
- Report number
- 2245578-2018-00084
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-02-04
- Date received
- 2018-03-02
- Adverse event
- 0
- 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 0 | I-STAT1 ANALYZER | I-STAT1 ANALYZER | ABBOTT POINT OF CARE | GKF | NA | 04P75-30 | NA | Y | R | |||
| 1 | I-STAT1 ANALYZER | I-STAT1 ANALYZER | ABBOTT POINT OF CARE | CGA | NA | 04P75-30 | NA | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-03-02 | 0 |
Event Narratives#
D
Patient 1
ON (B)(6) 2018, AN ABBOTT POINT OF CARE DISTRIBUTOR WAS CONTACTED BY A CUSTOMER REGARDING AN I-STAT 1 ANALYZER THAT YIELDED SUSPECTED DISCREPANT HEMATOCRIT/HEMOGLOBIN RESULTS ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. PRODUCT IS AVAILABLE FOR INVESTIGATION. (B)(6). THE CUSTOMER STATES THAT THE TESTS FOR I-STAT WERE DONE ON THE SAME PATIENT LESS THAN 3 HOURS APART. TEST/COLLECTION TIMES ARE UNK. 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.