MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-20 for ARCHITECT SIROLIMUS 01L76-25 manufactured by Abbott Laboratories.
[100772504]
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
[100772505]
The customer reported falsely elevated architect sirolimus results for one patient. The customer indicated the undiluted sample (b)(6) generated an initial result of >30 ng/ml and diluted 1:2 generated 9. 8 ng/ml. The sample was retested and undiluted generated >30 ng/ml and diluted 1:2 generated 12. 83 ng/ml. The customer further reported a second technician setup and ran the sample obtaining an undiluted result of >30 ng/ml and diluted 1:2 generated 33. 86 ng/ml. No adverse impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1415939-2018-00021 |
| MDR Report Key | 7283278 |
| Date Received | 2018-02-20 |
| Date of Report | 2018-03-19 |
| Date of Event | 2018-02-01 |
| Date Mfgr Received | 2018-03-04 |
| Device Manufacturer Date | 2017-08-01 |
| Date Added to Maude | 2018-02-20 |
| 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 | 0 |
| Brand Name | ARCHITECT SIROLIMUS |
| Generic Name | SIROLIMUS |
| Product Code | NRP |
| Date Received | 2018-02-20 |
| Catalog Number | 01L76-25 |
| Lot Number | 77007M800 |
| Device Expiration Date | 2018-12-13 |
| 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 LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK ROAD ABBOTT PARK IL 600643500 US 600643500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-20 |