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 2020-03-31 for MAGNESIUM 03P6832 03P68-32 manufactured by Abbott Gmbh.
[188735540]
Patient information: no further patient information was provided by the customer. An evaluation is in process. A follow-up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[188735541]
The customer observed a falsely elevated magnesium result generated on the architect c8000 processing module for 1 sample. The following data was provided (normal range: 0. 65 to 1. 05 mmol/l): 09mar2020 sid p5091588 initial result = 2. 63 mmol/l, repeat = 0. 79 mmol/l. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002809144-2020-00255 |
| MDR Report Key | 9904050 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-31 |
| Date of Report | 2020-04-03 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-04-02 |
| Device Manufacturer Date | 2019-08-22 |
| Date Added to Maude | 2020-03-31 |
| 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 GMBH |
| Manufacturer Street | MAX-PLANCK-RING 2 |
| Manufacturer City | WIESBADEN 65205 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 65205 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAGNESIUM |
| Generic Name | MAGNESIUM |
| Product Code | JGJ |
| Date Received | 2020-03-31 |
| Model Number | 03P6832 |
| Catalog Number | 03P68-32 |
| Lot Number | 33532UN19 |
| 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 GMBH |
| Manufacturer Address | MAX-PLANCK-RING 2 WIESBADEN 65205 GM 65205 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |