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 2017-01-26 for ARCHITECT CA 125 II 02K45-23 manufactured by Abbott Laboratories.
[65842704]
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
[65842705]
The customer stated that a falsely elevated architect ca 125 result of 213 u/ml was generated. The patient was tested at another laboratory (method unknown) and the results were in the normal range. The customer repeated the sample and a result of > 200 u/ml was generated. There was no report of impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
[68984211]
No patient sample was available for testing. Accuracy testing was performed to evaluate the performance of architect ca125 ii reagent lot 62009m800. An internal panel was tested with retained kits of the likely cause reagent lot. Acceptance criteria were met, which indicates acceptable product performance. Customer complaint data was reviewed and no adverse trends were identified. The architect ca 125 ii reagent package insert was reviewed and was found to adequately address the issue. The investigation did not identify a product deficiency.
Patient Sequence No: 1, Text Type: N, H10
[74819431]
The device evaluation was reassessed and concluded that a malfunction occurred, therefore, the device was not performing as intended at the customer site. However no systemic issue and/or product deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2017-00005 |
| MDR Report Key | 6279736 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-01-26 |
| Date of Report | 2017-04-27 |
| Date of Event | 2017-01-09 |
| Date Mfgr Received | 2017-04-14 |
| Device Manufacturer Date | 2016-05-01 |
| Date Added to Maude | 2017-01-26 |
| 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 |
| 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 LABORATORIES |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600643500 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 600643500 |
| 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 | 2017-01-26 |
| Catalog Number | 02K45-23 |
| Lot Number | 62009M800 |
| Device Expiration Date | 2017-03-10 |
| 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 LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK ROAD ABBOTT PARK IL 600643500 US 600643500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-26 |