MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-06 for MAGNESIUM 03P68-31 manufactured by Abbott Gmbh.
[188235824]
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 the customer.
Patient Sequence No: 1, Text Type: N, H10
[188235825]
The customer reported falsely elevated magnesium (mg) results on three patients generated on the architect analyzer. The results provided were: on (b)(6) 2019 pt#1 initial mg = 7. 2mg/dl / retested on different architect = 1. 8mg/dl (normal range 1. 6-2. 6mg/dl); on (b)(6) 2019 pt#2 = 6. 2mg/dl / retested on different architect = 2. 1mg/dl. On (b)(6) 2019 sample from (b)(6) 2019 was retested = 6. 0 / repeat =2. 0mg/dl. There was no reported impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002809144-2020-00015 |
| MDR Report Key | 9555171 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-06 |
| Date of Report | 2020-01-21 |
| Date of Event | 2019-12-11 |
| Date Mfgr Received | 2020-01-21 |
| Date Added to Maude | 2020-01-06 |
| 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 | 2020-01-06 |
| Catalog Number | 03P68-31 |
| Lot Number | 07588UN19 |
| Device Expiration Date | 2020-04-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-01-06 |