MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-02-28 for CLINICAL CHEMISTRY MAGNESIUM 07D70-21 manufactured by Abbott Manufacturing Inc.
[137541705]
Patient identifier: multiple = sid (b)(6), sid (b)(6). An evaluation is in process. A final report will be submitted when the evaluation is complete. There is no further patient information provided by the customer.
Patient Sequence No: 1, Text Type: N, H10
[137541706]
The customer reported falsely elevated magnesium results generated on the architect analyzer for two patients. The results provided were: sid (b)(6): first architect = 2. 1 / repeated on second architect = 1. 4 /1. 3mg/dl (normal range 1. 6 - 2. 6mg/dl); sid (b)(6): first architect =2. 0 / repeat on second architect = 1. 3 / 1. 2mg/dl. There was no reported impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2019-00171 |
| MDR Report Key | 8378820 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-02-28 |
| Date of Report | 2019-06-21 |
| Date Mfgr Received | 2019-06-14 |
| Device Manufacturer Date | 2018-10-13 |
| Date Added to Maude | 2019-02-28 |
| 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 MAGNESIUM |
| Generic Name | MAGNESIUM |
| Product Code | JGJ |
| Date Received | 2019-02-28 |
| Catalog Number | 07D70-21 |
| Lot Number | 95220UN18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-02-28 |