MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-18 for VITROS 5600 INTEGRATED SYSTEM 6802413 manufactured by Ortho-clinical Diagnostics.
[73254607]
The investigation determined that a lower than expected ckmb result was obtained from a patient sample processed using vitros ckmb slides on a vitros 5600 integrated system. The most likely assignable cause for the event is instrument related, as a within-run precision test was outside of ortho clinical diagnostic guidelines, indicating the vitros 5600 system was not performing as intended. The ortho field engineer performed service actions and the post service within-run precision was acceptable indicating the vitros 5600 system was performing as expected. Following service actions, acceptable vitros ckmb performance was observed.
Patient Sequence No: 1, Text Type: N, H10
[73254608]
The customer observed a lower than expected ckmb result from a patient sample (2. 2 ng/ml versus expected 3. 0 ng/ml) processed using vitros ckmb reagent on a vitros 5600 integrated system. Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples. The lower than expected results were not reported from the laboratory. There were no allegations of patient harm as a result of the event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319681-2017-00028 |
| MDR Report Key | 6499527 |
| Date Received | 2017-04-18 |
| Date of Report | 2017-04-18 |
| Date of Event | 2017-03-23 |
| Date Mfgr Received | 2017-03-23 |
| Device Manufacturer Date | 2013-03-14 |
| Date Added to Maude | 2017-04-18 |
| 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 | JHW |
| Date Received | 2017-04-18 |
| 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 |
| Brand Name | VITROS 5600 INTEGRATED SYSTEM |
| Generic Name | CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-04-18 |
| 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 | 2017-04-18 |