MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-02-10 for VITROS 5600 INTEGRATED SYSTEM 6802413 manufactured by Ortho-clinical Diagnostics.
[20459549]
A customer observed a lower than expected dgxn quality control result from a bio-rad qc fluid when using vitros chemistry products dgxn slides on a vitros 5600 integrated system. Bio-rad l3= 0. 63 vs. Expected 2. 75 ng/ml. Biased results of the magnitude and direction observed may lead to inappropriate physician action. No patient samples were processed while the dgxn quality control results were outside of expected ranges; however, the investigation cannot conclude that patient samples would not be affected if the event were to recur undetected. There was no allegation 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
[20564223]
The investigation confirmed that a lower than expected dgxn quality control result was obtained from a bio-rad qc fluid when using vitros chemistry products dgxn slides on a vitros 5600 integrated system. The most likely root cause of this event is analyzer related. There was no indication the vitros dgxn reagent contributed to the event. Following service actions, acceptable qc results have been maintained indicating that service actions have resolved the issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319681-2015-00014 |
| MDR Report Key | 4502421 |
| Report Source | 05 |
| Date Received | 2015-02-10 |
| Date of Report | 2015-02-10 |
| Date of Event | 2015-01-13 |
| Date Mfgr Received | 2015-01-13 |
| Device Manufacturer Date | 2012-07-19 |
| Date Added to Maude | 2015-03-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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. JAMES A STEVENS |
| 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 | KXT |
| Date Received | 2015-02-10 |
| Catalog Number | 6802413 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| 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 | 2015-02-10 |