MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2013-07-18 for ARCHITECT CYCLOSPORINE 01L75-25 manufactured by Abbott Laboratories.
[3653965]
The customer stated that discrepant architect cyclosporine results were generated. An initial result of 600 ng/ml was generated. The sample was retested and a result of 680 ng/ml was generated. The following day a new sample was obtained and a result of 120 ng/ml was generated. This sample was retested and a result of 124 ng/ml was obtained. Further cyclosporine results from the patient were as follows. (b)(6). The customer indicated that the issue may have been due to an increase in the drip rate by the attending nurse. There was no report of impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
[10902416]
(b)(4). 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
[26492379]
Review of customer information; tracking and trending review. Additional information was provided by the customer. They indicated that the cause of the discrepant results was due to the administration of the cyclosporine medication and the results were accurate. Customer complaint data was reviewed and no adverse trends were identified for the issue under investigation. The architect cyclosporine reagent package insert and the architect system operation manual were reviewed and were found to adequately address the issue. The investigation did not identify a malfunction / deficiency.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2013-00294 |
| MDR Report Key | 3232725 |
| Report Source | 01,05 |
| Date Received | 2013-07-18 |
| Date of Report | 2013-06-26 |
| Date of Event | 2013-06-25 |
| Date Mfgr Received | 2013-09-26 |
| Device Manufacturer Date | 2013-01-01 |
| Date Added to Maude | 2013-07-24 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT CYCLOSPORINE |
| Product Code | MKW |
| Date Received | 2013-07-18 |
| Catalog Number | 01L75-25 |
| Lot Number | 21307M500 |
| Device Expiration Date | 2013-10-24 |
| Operator | OTHER |
| 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 60064350 US 60064 3500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-07-18 |