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 2019-03-11 for CLINICAL CHEMISTRY MAGNESIUM 07D70-21 manufactured by Abbott Manufacturing Inc.
[138541919]
Patient identifier: multiple = (b)(6), (b)(6), (b)(6), (b)(6), (b)(6), (b)(6), (b)(6), (b)(6), (b)(6), (b)(6), (b)(6), (b)(6). A product correction letter was issued to all magnesium customers who have received one of the impacted lots. The letter instructs the customer to discontinue use of the magnesium urine application. New customers will receive product with a kit stuffer that includes instructions to immediately discontinue use of the 7d70 magnesium urine application.
Patient Sequence No: 1, Text Type: N, H10
[138541920]
The customer reported falsely depressed urine magnesium results were generated while using the magnesium urine application. The following sids generated results < 1. 50 mg/dl: sid (b)(6), sid (b)(6), sid (b)(6), sid (b)(6), sid (b)(6), sid (b)(6), sid (b)(6), sid (b)(6), sid (b)(6), sid (b)(6), sid (b)(6), sid (b)(6). No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2019-00191 |
| MDR Report Key | 8410245 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-03-11 |
| Date of Report | 2019-03-11 |
| Date of Event | 2019-02-14 |
| Date Mfgr Received | 2019-02-20 |
| Device Manufacturer Date | 2018-07-19 |
| Date Added to Maude | 2019-03-11 |
| 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 | 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 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | 1628664-01/8/19-001-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINICAL CHEMISTRY MAGNESIUM |
| Generic Name | MAGNESIUM |
| Product Code | JGJ |
| Date Received | 2019-03-11 |
| Catalog Number | 07D70-21 |
| Lot Number | 33784UN18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2019-03-11 |