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 2019-03-29 for CLINICAL CHEMISTRY MAGNESIUM 03P68-21 manufactured by Abbott Manufacturing Inc.
[140315385]
This event was previously reported under manufacturer report number 1415939-2018-00168, with the incorrect manufacturing location. Any further information will be provided under this mdr report number. An investigation was performed by reviewing the complaint text, service history, tracking and trending metrics, and the current labeling for the magnesium package insert and the architect system operations manual. Review of complaint activity did not identify other complaints for the likely cause lot 99555un18. Tracking and trending for the magnesium assay determined there were no adverse or non-statistical trends. No nonconformances were identified related to this issue. A review of the product labeling concluded that the issue is sufficiently addressed. No systemic issue or deficiency of the architect magnesium assay was identified.
Patient Sequence No: 1, Text Type: N, H10
[140315386]
The customer reported a falsely elevated architect magnesium initial result of 7. 18 mg/dl. Repeat result was 1. 88 mg/dl. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2019-00264 |
| MDR Report Key | 8464199 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-03-29 |
| Date of Report | 2019-03-29 |
| Date of Event | 2018-11-25 |
| Date Mfgr Received | 2019-03-05 |
| Device Manufacturer Date | 2018-05-01 |
| Date Added to Maude | 2019-03-29 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINICAL CHEMISTRY MAGNESIUM |
| Generic Name | MAGNESIUM |
| Product Code | JGJ |
| Date Received | 2019-03-29 |
| Catalog Number | 03P68-21 |
| Lot Number | 99555UN18 |
| Device Expiration Date | 2019-03-26 |
| 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 | 2019-03-29 |