MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2012-11-21 for ARCHITECT CYCLOSPORINE 01L75-25 manufactured by Abbott Laboratories.
[3047027]
The customer stated cyclosporine results were out of range low on an architect i1000sr analyzer. There was no adverse impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[10318455]
(b)(4). The cause of the archtiect cyclosporine imprecision is due to an interaction between the architect cylcosporine assay and the resin used to produce certain architect reaction vessel (rv) lots. Assay precision can be impacted if rvs containing different resin are mixed in the architect hopper and used to test architect cyclosporine. All architect cyclosporine customers will be instructed to only run architect cyclosporine using rvs manufactured with resin from the same supplier. Rv lots beginning with lot 06083p100 and higher can be used together. Rv lots lower than 06083p100 can be used together.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2012-02081 |
| MDR Report Key | 2842790 |
| Report Source | 01 |
| Date Received | 2012-11-21 |
| Date of Report | 2012-09-11 |
| Date Mfgr Received | 2012-11-09 |
| Date Added to Maude | 2012-11-23 |
| 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 | 0 |
| Event Location | 0 |
| 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 | 847937-512 |
| Manufacturer G1 | ABBOTT LABORATORIES |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 60064350 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60064 3500 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | 1415939-10/10/11-002-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT CYCLOSPORINE |
| Product Code | MKW |
| Date Received | 2012-11-21 |
| Catalog Number | 01L75-25 |
| Lot Number | 13089M500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 60064350 US 60064 3500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-11-21 |