N
Patient 1
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. PATIENT INFORMATION: NO SPECIFIC PATIENT INFORMATION WAS PROVIDED.
MAUDE MDR 8006894
- MDR report key
- 8006894
- Report number
- 1628664-2018-01972
- Event key
- 0
- Event type
- 3
- Date received
- 2018-10-25
- 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
- NOEMI ROMERO-KONDOS, RN BSN
- Address
- 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 ABBOTT PARK IL 60064 US
- Phone
- 224-224-2246
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | CLINICAL CHEMISTRY CALCIUM | CALCIUM | ABBOTT MANUFACTURING INC | CJY | 03L79-21 | 98314UN17 | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-10-25 | 0 |
Event Narratives#
D
Patient 1
THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT CALCIUM RESULT. SAMPLE ID IA0900329SS GENERATED AN INITIAL RESULT OF 10.92 MEQ/L. THE SAMPLE WAS RETESTED MULTIPLE TIMES RANGING FROM 3.51 MEQ/L TO 4.98 MEQ/L. THE CUSTOMER USES A NORMAL RANGE OF 4.09 TO 5.58 MEQ/L. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.