MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-04-03 for VITROS 250 CHEMISTRY SYSTEM 8132086 manufactured by Ortho-clinical Diagnostics.
[14929718]
A customer observed a lower than expected vitros phyt result (<3. 0 ug/ml) on a single proficiency fluid while using the vitros 250 chemistry system. The proficiency fluid's expected result was 6. 69 ug/ml. Biased results of the magnitude and direction observed may lead to inappropriate physician action if patient samples were affected. The customer made no allegations that patient sample results were affected. There was no report of patient harm as a result of this event. This report corresponds to ortho clinical diagnostics inc. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[15294916]
The investigation found no evidence to suggest that either the vitros 250 or the vitros phyt slides malfunctioned. The investigation determined that a "no result" was generated for phyt on the affected proficiency fluid sample due to the matrix of the fluid. In addition to the "no result", the vitros 250 generated a condition code. The operator did not respond to appropriately to an associated analyzer condition code. When the vitros 250 analyzer displays a generated condition code, an error text is displayed that provides information on how to interpret the analyzer codes. The root cause of the reported lower than expected phyt proficiency fluid result was user error, as the operator incorrectly interpreted the analyzer condition code as indicating a phyt result below the analyzer's reportable range, when in fact a result could not be obtained due to the matrix of the proficiency fluid. The customer was made aware of the improper response to the condition code to avoid additional misinterpretation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319681-2012-00053 |
| MDR Report Key | 2515513 |
| Report Source | 05 |
| Date Received | 2012-04-03 |
| Date of Report | 2012-04-03 |
| Date of Event | 2012-01-27 |
| Date Mfgr Received | 2012-03-05 |
| Device Manufacturer Date | 2000-01-05 |
| 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 250 CHEMISTRY SYSTEM |
| Generic Name | CHEMISTRY ANALYZER |
| Product Code | DKH |
| Date Received | 2012-04-03 |
| Catalog Number | 8132086 |
| 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 | 2012-04-03 |