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 2012-06-26 for VITROS 5,1 FS CHEMISTRY SYSTEM 6801375 manufactured by Ortho-clinical Diagnostics.
[2728853]
The customer obtained discordant vitros phyt results for three patient samples (sample 1 result <3. 0 ug/ml; sample 2 result = 20. 8 ug/ml; sample 3 result = 5. 3 ug/ml) while using the vitros 5,1 fs chemistry system. Biased results of the direction and magnitude observed may lead to inappropriate physician action. The affected phyt patient results were reported to a clinician, who questioned the results. The affected patient samples were repeated at an external laboratory (repeat sample 1 result = 5. 1 ug/ml; repeat sample 2 result = 17. 0 ug/ml; repeat sample 3 result = 11. 1 ug/ml), and the repeat results were considered to be correct. However, there was no change in patient treatment based on the initial report results. There were no allegations of harm to patients as a result of this event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10114190]
The investigation confirmed that unexpected vitros phyt patient results were obtained while using the vitros 5,1 fs analyzer. Precision testing indicated that the instrument was not performing as expected at the time of the event. An ocd field engineer performed service actions to the incubator subsystem and performed related adjustments. Performance testing following service confirmed that the equipment was returned to expected operation. The assignable root cause is an instrument related issue. There is no evidence that the vitros phyt slides malfunctioned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319681-2012-00125 |
| MDR Report Key | 2628226 |
| Report Source | 00,01,05 |
| Date Received | 2012-06-26 |
| Date of Report | 2012-06-25 |
| Date of Event | 2012-05-25 |
| Date Mfgr Received | 2012-05-25 |
| Device Manufacturer Date | 2008-06-25 |
| Date Added to Maude | 2012-10-16 |
| 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 | 2012-06-26 |
| 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 | 2012-06-26 |