N
Patient 1
AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED.
MAUDE MDR 9598252
- MDR report key
- 9598252
- Report number
- 1628664-2020-00019
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-08-23
- Date received
- 2020-01-16
- 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
- CHRISTIAN LEE
- Address
- 100 ABBOTT PARK ROAD DEPT 09B9, BLDG CP01-3 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 | CALCIUM | CALCIUM | ABBOTT MANUFACTURING INC | CJY | 3L79-21 | 03L79-21 | 61158UN18 | Y | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-01-16 | 0 | 1. R |
Event Narratives#
D
Patient 1
THE ACCOUNT GENERATED FALSE ELEVATED ARCHITECT CALCIUM OF 3.03 MMOL/L WITH SID (B)(6) ON (B)(6) 2019 MORNING ON A (B)(6)-YEAR OLD CAUCASIAN FEMALE LUNG CANCER PROGRESSIVE MALIGNANCY PATIENT WHO WAS TREATED WITH APD INFUSION (BIPHOSPHONATES INFUSION - PAMIDRONATES) DUE TO THE ELEVATED CALCIUM RESULT. THE SAMPLE REPEATED ARCHITECT CALCIUM OF 2.46 MMOL/L ON (B)(6) 2019 AT 15:35 WHICH WAS THE CORRECT RESULT REPORTED TO THE PHYSICIAN BUT THE APD INFUSION HAD FINISHED. ADDITIONAL TESTING WAS CALCIUM OF 2.33 MMOL/L ON (B)(6) 2019 AND 2.16 MMOL/L ON (B)(6) 2019. PRIOR TO APD INFUSION, THE PATIENT WAS VERY SICK. DAYS AFTER THE APD INFUSION, THE PATIENT WENT TO THE HOSPITAL WITH FEVER, DID NOT FEEL WELL AND BLAMED THE APD INFUSION. THE PATIENT RECEIVED AMOXI IV AS TREATMENT FOR THE FEVER. THE PATIENTS PLANNED CHEMOTHERAPY WAS POSTPONED 7 DAYS DUE TO THE ELEVATED CALCIUM RESULT. HISTORICAL PATIENT CALCIUM WAS 2.32 MMOL/L ((B)(6) 2002), 2.43 MMOL/L ((B)(6) 2002), 2.42 MMOL/L ((B)(6) 2002), 2.37 MMOL/L ((B)(6) 2002), 2.33 MMOL/L ((B)(6) 2003), 2.24 MMOL/L ((B)(6) 2018), 2.37 MMOL/L ((B)(6) 2019), 2.41 MMOL/L ((B)(6) 2019), 2.40 MMOL/L ((B)(6) 2019), 2.43 MMOL/L ((B)(6) 2019), 2.45 MMOL/L ((B)(6) 2019), 2.55 MMOL/L ((B)(6) 2019), 2.46 MMOL/L ((B)(6) 2019), 2.43 MMOL/L ((B)(6) 2019), 2.47 MMOL/L ((B)(6) 2019), 2.44 MMOL/L ((B)(6) 2019), 2.48 MMOL/L ((B)(6) 2019), 2.55 MMOL/L ((B)(6) 2019), 2.39 MMOL/L ((B)(6) 2019). THE ACCOUNT USES A CALCIUM REFERENCE RANGE OF 2.10 TO 2.65 MMOL/L.