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 2019-04-15 for ALINITY C CALCIUM 07P57-20 manufactured by Abbott Germany.
[142211397]
All available patient information was included. Additional patient details are not available. An evaluation is in process. A final report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[142211398]
The customer observed falsely elevated calcium results on the alinity c analyzer. The following data was provided: sid (b)(6): initial 5. 03, repeat 2. 46 mmol/l. There was no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002809144-2019-00200 |
| MDR Report Key | 8516010 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-04-15 |
| Date of Report | 2019-06-28 |
| Date Mfgr Received | 2019-06-27 |
| Device Manufacturer Date | 2018-07-13 |
| Date Added to Maude | 2019-04-15 |
| 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 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 | 3 |
| Brand Name | ALINITY C CALCIUM |
| Generic Name | CALCIUM |
| Product Code | CJY |
| Date Received | 2019-04-15 |
| Catalog Number | 07P57-20 |
| Lot Number | 32866UN18 |
| Device Expiration Date | 2019-05-23 |
| 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 | 2019-04-15 |