MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2015-03-16 for THE PRO-TRAC II TACROLIMUS ELISA KIT 32400/32400-CN manufactured by Diasorin, Inc..
[5654316]
The pro-trac ii tacrolimus elisa kit is failing multiple internal specifications: absorbance of the calibrator zero (od), calibrator 1 (od) - calibrator 5 (od), calibrator 1 (od) - calibrator zero(od). Diasorin inc has confirmed that the failure manifests as a decrease in the total assay signal resulting in a shift in the calibration curve. This shift may cause discordant elevated tacrolimus results to be reported on a patient's sample. Evaluation summary attached.
Patient Sequence No: 1, Text Type: D, B5
[13106320]
No customer reports of injury or illness have been received. This report does not reflect a conclusion by diasorin that this product caused or contributed to any alleged injury or illness. This report is being submitted in compliance with the mdr regulations.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2182595-2015-00001 |
| MDR Report Key | 4616031 |
| Report Source | 00 |
| Date Received | 2015-03-16 |
| Date of Report | 2015-02-17 |
| Date Mfgr Received | 2015-02-17 |
| Device Manufacturer Date | 2014-12-01 |
| Date Added to Maude | 2015-05-01 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARI MEYER |
| Manufacturer Street | 1951 NORTHWESTERN AVE. PO BOX 285 |
| Manufacturer City | STILLWATER MN 550820285 |
| Manufacturer Country | US |
| Manufacturer Postal | 550820285 |
| Manufacturer Phone | 6513515635 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THE PRO-TRAC II TACROLIMUS ELISA KIT |
| Generic Name | ENZYME IMMUNOASSAY, TACROLIMUS |
| Product Code | MLM |
| Date Received | 2015-03-16 |
| Catalog Number | 32400/32400-CN |
| Lot Number | 131716/131717 |
| Device Expiration Date | 2015-07-30 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DIASORIN, INC. |
| Manufacturer Address | 1951 NORTHWESTERN AVE. PO BOX 285 STILLWATER MN 55082028 US 55082 0285 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-16 |