MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-14 for CLINICAL CHEMISTRY MAGNESIUM 03P68-32 manufactured by Abbott Germany.
[145113860]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. No specific patient information was provided by the customer.
Patient Sequence No: 1, Text Type: N, H10
[145113861]
The customer reported falsely elevated architect magnesium results. The sample generated an initial result of 2. 97 mmol/l and retest of 0. 86 mmol/l. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002809144-2019-00291 |
| MDR Report Key | 8609105 |
| Date Received | 2019-05-14 |
| Date of Report | 2019-07-26 |
| Date Mfgr Received | 2019-07-15 |
| Device Manufacturer Date | 2019-01-16 |
| Date Added to Maude | 2019-05-14 |
| 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 GERMANY |
| 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 | 0 |
| Brand Name | CLINICAL CHEMISTRY MAGNESIUM |
| Generic Name | MAGNESIUM |
| Product Code | JGJ |
| Date Received | 2019-05-14 |
| Catalog Number | 03P68-32 |
| Lot Number | 46459UN18 |
| Device Expiration Date | 2019-11-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT GERMANY |
| Manufacturer Address | MAX-PLANCK-RING 2 WIESBADEN 65205 GM 65205 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-14 |