N
Patient 1
APOC INCIDENT # (B)(4). APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.
MAUDE MDR 8180347
- MDR report key
- 8180347
- Report number
- 2245578-2018-00317
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-11-27
- Date received
- 2018-12-19
- 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 CG4+ CARTRIDGE | CG4+ CARTRIDGE | ABBOTT POINT OF CARE | KHP | NA | 03P85-25 | Y | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-12-19 | 0 | 1. D |
Event Narratives#
D
Patient 1
ON 12/07/2018, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG4+ CARTRIDGES (LOT# UNK) THAT YIELDED SUSPECTED DISCREPANT RESULTS ON AN (B)(6) PATIENT WITH DIABETES. THE CUSTOMER STATED THAT THE PATIENT WAS ALREADY VERY CRITICAL WHEN ADMITTED AND LATER EXPIRED. CAUSE OF DEATH IS UNKNOWN AT THE TIME OF THIS REPORT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. METHOD, DATE, RESULT, SAMPLE: I-STAT, (B)(6) 2018,
N
Patient 1
APOC INCIDENT # (B)(4). THE INVESTIGATION WAS COMPLETED ON 02/19/2019. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THE CARTRIDGE LOT MET FINISHED GOODS (FG) RELEASE CRITERIA. RETAINED TESTING MET THE ACCEPTANCE CRITERIA OUTLINED IN APPENDIX 1 OF Q04.01.003 REV. AC (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE). NO DEFICIENCY HAS BEEN DETERMINED FOR CG4+ LOT M18163A.
D
Patient 1