MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-08-24 for VITROS 350 CHEMISTRY SYSTEM 6802153 manufactured by Ortho-clinical Diagnostics.
[2799547]
The customer obtained a non-reproducible, higher than expected vitros phyt proficiency sample result (api# ch-08 result = 18. 8 ug/ml vs. And expected result of 14. 53 ug/ml) while using the vitros 350 chemistry system. Biased results of the magnitude and direction observed may lead to inappropriate physician action if the event were to recur undetected with patient samples. Patient samples were not known to have been affected. There was no allegation of harm to patients as a result of this event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10012580]
The investigation confirmed that a non-reproducible, higher than expected vitros phyt proficiency sample result was obtained while using the vitros 350 analyzer. An ocd field engineer performed service actions to multiple analyzer subsystems. Performance testing following service verified that the equipment was returned to expected operation. The investigation determined that the most likely assignable cause of the event is an instrument related issue. There is no evidence that the vitros phyt slides had malfunctioned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319681-2012-00168 |
| MDR Report Key | 2714110 |
| Report Source | 05 |
| Date Received | 2012-08-24 |
| Date of Report | 2012-08-24 |
| Date of Event | 2012-07-25 |
| Date Mfgr Received | 2012-07-25 |
| Device Manufacturer Date | 2012-05-24 |
| Date Added to Maude | 2012-12-11 |
| 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 350 CHEMISTRY SYSTEM |
| Generic Name | CHEMISTRY ANALYZER |
| Product Code | DKH |
| Date Received | 2012-08-24 |
| Catalog Number | 6802153 |
| 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 | 2012-08-24 |