MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-23 for VITROS 5600 INTEGRATED SYSTEM 6802413 manufactured by Ortho-clinical Diagnostics.
[78461129]
The investigation determined that lower than expected myoglobin results were obtained from biorad level 1 quality control fluid using vitros myoglobin reagent on a vitros 5600 integrated system. The assignable cause was determined to be instrument related. Reagent and sample metering condition codes were being posted by the instrument at the time the lower than expected vitros myog results were generated. Ortho technical support reviewed historical biorad qc fluid performance across the two vitros 5600 systems in the laboratory and only one vitros system showed myoglobin imprecision suggesting that the issue is most likely instrument and not reagent related. The customer performed maintenance actions of flushing the reagent and sample metering probes. Following these actions, acceptable within run precision results were obtained on the affected vitros 5600 system. In addition, acceptable biorad qc performance has maintained following maintenance actions.
Patient Sequence No: 1, Text Type: N, H10
[78461130]
The investigation determined that lower than expected myoglobin results (54, 54. 143, 51. 89, 52. 517, 53. 724 and 53. 7 ng/ml versus expected 64. 3 ng/ml) were obtained from a non-vitros biorad level 1 (lot 29851) quality control fluid processed using vitros immunodiagnostics products myoglobin reagent lot 1220 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 unexpected vitros myoglobin results were generated from non-patient fluids, however the investigation cannot conclude that patient sample results were not affected and would not be affected if the event were to recur undetected. There was no allegation of patient harm as a result of the event. This report corresponds to ortho clinical diagnostics inc. Complaint number 1910053 / ivd 406334.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319681-2017-00046 |
| MDR Report Key | 6662841 |
| Date Received | 2017-06-23 |
| Date of Report | 2017-06-23 |
| Date of Event | 2017-05-20 |
| Date Mfgr Received | 2017-05-28 |
| Device Manufacturer Date | 2016-11-10 |
| Date Added to Maude | 2017-06-23 |
| 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 | 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 | DDR |
| Date Received | 2017-06-23 |
| 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 | 2017-06-23 |
| 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 | 2017-06-23 |