MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-17 for VITROS 5600 INTEGRATED SYSTEM 6802413 manufactured by Ortho-clinical Diagnostics.
[38998801]
The investigation has determined that higher than expected amon results were obtained from non vitros quality control fluids using vitros amon reagent on a vitros 5600 integrated system. A likely assignable cause for the higher than expected amon results is user error due to pre-analytical sample handling. Acceptable performance was obtained when fresh pours of control fluids that were properly handled were retested. There was no indication the vitros amon reagent or the vitros 5600 system malfunctioned.
Patient Sequence No: 1, Text Type: N, H10
[38998802]
The customer obtained higher than expected amon results from two levels of non vitros quality control fluids using vitros amon reagent on a vitros 5600 integrated system. Level 1 vitros amon result 112 umol/l versus the expected amon result 80. 3 umol/l level 2 vitros amon result 301 umol/l versus the expected amon result 212 umol/l biased results of the direction and magnitude observed may lead to inappropriate physician action. The customer stated that vitros amon patient samples were not processed during the time frame of the event. However, the investigation cannot conclude that patient sample results 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. Complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319681-2016-00029 |
| MDR Report Key | 5442829 |
| Date Received | 2016-02-17 |
| Date of Report | 2016-02-17 |
| Date of Event | 2016-01-11 |
| Date Mfgr Received | 2016-01-22 |
| Device Manufacturer Date | 2010-01-25 |
| Date Added to Maude | 2016-02-17 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 | 0 |
| Brand Name | VITROS 5600 INTEGRATED SYSTEM |
| Generic Name | CHEMISTRY ANALYZER |
| Product Code | JIF |
| Date Received | 2016-02-17 |
| 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 | 2016-02-17 |