MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-04-11 for VITROS 5,1 FS CHEMISTRY SYSTEM 6801375 manufactured by Ortho-clinical Diagnostics.
[21765008]
A customer observed higher than expected and imprecise vitros phyt quality control results obtained from two different vitros performance verifier control fluids on a vitros 5,1 fs chemistry system. Tdm performance verifier lot d9984: 11. 53 ug/ml vs. The established customer mean of 9. 0. Tdm performance verifier lot f9986: 37. 98, >40. 0, >40. 0, >40. 0, and 37. 27 ug/ml vs. The established customer mean of 29. 09. Biased results of the magnitude and direction observed may lead to inappropriate physician action if patient samples were affected. Patient samples were not tested for vitros phyt while quality control results were outside of expected ranges. There was no report of patient harm as a result of this event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[21925978]
The investigation determined higher than expected and imprecise vitros phyt quality control results were obtained from two different vitros performance verifier control fluids on a vitros 5,1 fs chemistry system. The root cause of this event is analyzer related. Phyt performance tests were outside of ocd guidelines on two different phyt reagent lots. Ocd field service performed service actions to reflectometer and immuno-wash subsystems of the 5,1 fs analyzer. Acceptable vitros phyt performance was observed after service actions were completed. The investigation found no evidence the vitros phyt reagent malfunctioned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319681-2012-00065 |
| MDR Report Key | 2528033 |
| Report Source | 05 |
| Date Received | 2012-04-11 |
| Date of Report | 2012-04-11 |
| Date of Event | 2012-02-17 |
| Date Mfgr Received | 2012-03-14 |
| Device Manufacturer Date | 2007-11-09 |
| Date Added to Maude | 2012-04-12 |
| 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 | MR. JOSEPH FALVO |
| Manufacturer Street | 100 INDIGO CREEK DRIVE |
| Manufacturer City | ROCHESTER NY 14626 |
| Manufacturer Country | US |
| Manufacturer Postal | 14626 |
| Manufacturer Phone | 5854533000 |
| Manufacturer G1 | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Street | 100 INDIGO CREEK DRIVE |
| Manufacturer City | ROCHESTER NY 14626 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14626 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITROS 5,1 FS CHEMISTRY SYSTEM |
| Generic Name | CHEMISTRY ANALYZER |
| Product Code | DKH |
| Date Received | 2012-04-11 |
| Catalog Number | 6801375 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Address | 100 INDIGO CREEK DRIVE ROCHESTER NY 14626 US 14626 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-11 |