MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-05-31 for VITROS SALI CHEMISTRY SLIDES 1314343 manufactured by Ortho-clinical Diagnostics.
[16722382]
A customer observed repeatable negatively biased sali results during a correlation study on the 5, 1 fs analyzer. No biased results were reported. Biased results of the direction and magnitude observed may lead to inappropriate physician action. There was no report of pt harm as a result of this event. This report corresponds to ortho clinical diagnostics inc.
Patient Sequence No: 1, Text Type: D, B5
[16899791]
Investigation into this event found that the results did not correlate with another oem method. Repeat testing results using an alternate slide cart matched the original results. Qc results were acceptable. Calibrator responses and calibration parameters were acceptable. After obtaining fresh samples, acceptable correlation was obtained between vitros and the oem method. The biased results are confined to the original samples, and the customer is investigating the transfer containers from the original samples. The root cause of the biased results has not been determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319809-2007-00151 |
| MDR Report Key | 857656 |
| Report Source | 05 |
| Date Received | 2007-05-31 |
| Date of Report | 2007-05-03 |
| Date of Event | 2007-05-03 |
| Date Mfgr Received | 2007-05-03 |
| Device Manufacturer Date | 2007-02-01 |
| Date Added to Maude | 2008-02-04 |
| 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 | 0 |
| Manufacturer Contact | THOMAS SMITH |
| Manufacturer Street | 100 INDIGO CREEK DR |
| Manufacturer City | ROCHESTER NY 146525101 |
| Manufacturer Country | US |
| Manufacturer Postal | 146525101 |
| Manufacturer Phone | 5854533735 |
| Manufacturer G1 | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Street | 300 WEILAND RD. |
| Manufacturer City | ROCHESTER NY 14652 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14652 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITROS SALI CHEMISTRY SLIDES |
| Generic Name | IN VITRO DIAGNOSTIC |
| Product Code | DKJ |
| Date Received | 2007-05-31 |
| Model Number | NA |
| Catalog Number | 1314343 |
| Lot Number | 2226-0049-8138 |
| ID Number | NA |
| Device Expiration Date | 2008-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 957640 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Address | 100 INDIGO CREEK DR ROCHESTER NY 146525101 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-05-31 |