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 2018-07-23 for CLINICAL CHEMISTRY CALCIUM 03L79-21 manufactured by Abbott Manufacturing Inc.
[114725742]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. There is no further patient information provided by customer due to privacy issues.
Patient Sequence No: 1, Text Type: N, H10
[114725743]
The customer reported falsely elevated calcium results on one patient. The initial sample was drawn at the physicians site: sample from (b)(6) 2018 (b)(6) on (b)(6) 2018 ca = 4. 26 / 4. 16 / 4. 05 / 3. 9 mmol/l(2. 23-2. 5 mmol/l). The results were reported and the patient was sent to the emergency room where a new sample was drawn: (b)(6) ca = 2. 37. The original (b)(6) was repeated on (b)(6) 2018 ca = 2. 4; on (b)(6) 2018 different tube same draw (b)(6) ca run 21x and the results ranged from 1. 91 to 2. 06. There was no reported impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2018-00362 |
| MDR Report Key | 7710691 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-07-23 |
| Date of Report | 2018-09-10 |
| Date of Event | 2018-07-05 |
| Date Mfgr Received | 2018-09-07 |
| Device Manufacturer Date | 2018-04-01 |
| Date Added to Maude | 2018-07-23 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NOEMI ROMERO-KONDOS, RN BSN |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 224667-512 |
| 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 | CLINICAL CHEMISTRY CALCIUM |
| Generic Name | CALCIUM |
| Product Code | CJY |
| Date Received | 2018-07-23 |
| Catalog Number | 03L79-21 |
| Lot Number | 98314UN17 |
| Device Expiration Date | 2019-02-27 |
| 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 75038 US 75038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-23 |