MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-01-10 for VITROS 5600 INTEGRATED SYSTEM 6802413 manufactured by Ortho-clinical Diagnostics.
[2414816]
The customer obtained multiple, imprecise vitros phyt quality control results (biorad 40231 result = 8. 12 ug/ml vs. Expected result = 5. 3 ug/ml; biorad 40232 results = 8. 3, 15. 41, 16. 13 ug/ml vs. Expected result = 12. 0 ug/ml; biorad 40233 results = 9. 5, 23. 71, 24. 03 ug/ml vs. Expected result = 19. 4 ug/ml; tdm pv c9668 result = 22. 4 vs. Expected result = 28. 5 ug/ml) while using the vitros 5600 integrated system. Biased results of the direction and magnitude observed may lead to inappropriate physician action if the events were to recur with patient samples. There was no report of affected patient samples. There was no allegation of harm to patients as a result of this event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[9679974]
The investigation confirmed that multiple, imprecise phyt quality control results were obtained while using the vitros 5600 analyzer. Patient samples were not known to have been affected. An ocd field engineer performed service to the wash fluid metering subsystem and performed related adjustments. Performance testing and phyt qc testing following service verified that the equipment was returned to expected operation. There is no evidence that the vitros phyt reagent slides malfunctioned. The assignable root cause is an instrument related issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319681-2012-00005 |
| MDR Report Key | 2406917 |
| Report Source | 05 |
| Date Received | 2012-01-10 |
| Date of Report | 2012-01-10 |
| Date of Event | 2011-12-02 |
| Date Mfgr Received | 2011-12-12 |
| Device Manufacturer Date | 2011-03-08 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 5600 INTEGRATED SYSTEM |
| Generic Name | CHEMISTRY ANALYZER |
| Product Code | DKH |
| Date Received | 2012-01-10 |
| Catalog Number | 6802413 |
| 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 | 2012-01-10 |