MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-01-16 for CALCIUM 3L79-21 03L79-21 manufactured by Abbott Manufacturing Inc.
[176235476]
An evaluation is in process. A follow up report will be submitted when the evaluation is completed.
Patient Sequence No: 1, Text Type: N, H10
[176235477]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2020-00019 |
| MDR Report Key | 9598252 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-01-16 |
| Date of Report | 2020-03-06 |
| Date of Event | 2019-08-23 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2019-01-10 |
| Date Added to Maude | 2020-01-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTIAN LEE |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT 09B9, BLDG CP01-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 224668-294 |
| Manufacturer G1 | ABBOTT MANUFACTURING INC |
| Manufacturer Street | 1921 HURD DRIVE |
| Manufacturer City | IRVING TX 75038 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75038 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CALCIUM |
| Generic Name | CALCIUM |
| Product Code | CJY |
| Date Received | 2020-01-16 |
| Model Number | 3L79-21 |
| Catalog Number | 03L79-21 |
| Lot Number | 61158UN18 |
| Device Expiration Date | 2020-02-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MANUFACTURING INC |
| Manufacturer Address | 1921 HURD DRIVE IRVING TX 750383500 US 750383500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-16 |