MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05 report with the FDA on 2008-03-28 for VITROS CHEMISTRY PRODUCTS TOBRA REAGENT 680 1712 manufactured by Ortho-clinical Diagnostics, Inc..
[818976]
The customer obtained biased vitros tobra results on pt and proficiency samples during a method comparison between two vitros 5, 1 fs chemistry systems and a competitive system. Biased results of the direction and magnitude observed could lead to inappropriate physician action. The biased results were not reported and there was no report of pt harm as a result of this event. The report corresponds to ortho clinical diagnostics, inc.
Patient Sequence No: 1, Text Type: D, B5
[8025316]
The investigation determined that the vitros 5, 1 fs was operating as intended. The biased vitros tobra results were obtained during a method comparison with a competitive system. The definitive root cause is unk, but is most likely a combination of inappropriate sample storage (frozen) prior to the correlation study, inadequate mixing of the samples prior to processing, and the differences in the tobra calibrations in use at the time of the study.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319808-2008-00085 |
| MDR Report Key | 1022317 |
| Report Source | 00,01,05 |
| Date Received | 2008-03-28 |
| Date of Report | 2008-02-28 |
| Date of Event | 2008-02-21 |
| Date Mfgr Received | 2008-02-28 |
| Device Manufacturer Date | 2007-03-01 |
| Date Added to Maude | 2008-07-01 |
| 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 | JOE FALVO |
| Manufacturer Street | 100 INDIGO CREEK DRIVE |
| Manufacturer City | ROCHESTER NY 146525101 |
| Manufacturer Country | US |
| Manufacturer Postal | 146525101 |
| Manufacturer Phone | 5854535735 |
| Manufacturer G1 | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| Manufacturer Street | 1000 LEE ROAD |
| Manufacturer City | ROCHESTER NY 14606 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14606 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITROS CHEMISTRY PRODUCTS TOBRA REAGENT |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | LDO |
| Date Received | 2008-03-28 |
| Model Number | NA |
| Catalog Number | 680 1712 |
| Lot Number | 1513-01-7371 |
| ID Number | NA |
| Device Expiration Date | 2008-05-31 |
| 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 | 1019892 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| Manufacturer Address | 100 INDIGO CREEK DRIVE ROCHESTER NY 146525101 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-03-28 |