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 2019-02-01 for ARCHITECT CA 125 II 02K45-29 manufactured by Abbott Germany.
[134887258]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. There is no additional patient information provided.
Patient Sequence No: 1, Text Type: N, H10
[134887259]
The customer reported a false elevated ca125 initial result of 53. 4 u/ml, when processing on the architect i2000sr. Another tube from the same sample generated a result of 14. 3 u/ml. The sample was retested again and yielded results of 55. 2 u/ml and 51. 6 u/ml. A second sample was drawn and yielded results of 42. 1 u/ml and 25. 9 u/ml. Results from another architect gave a result of 28 u/ml. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002809144-2019-00035 |
| MDR Report Key | 8296473 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-02-01 |
| Date of Report | 2019-03-12 |
| Date Mfgr Received | 2019-02-13 |
| Device Manufacturer Date | 2018-09-01 |
| Date Added to Maude | 2019-02-01 |
| 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 | ARCHITECT CA 125 II |
| Generic Name | OC 125 DEFINED ANTIGEN |
| Product Code | LTK |
| Date Received | 2019-02-01 |
| Catalog Number | 02K45-29 |
| Lot Number | 92014M800 |
| 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 | 2019-02-01 |