MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-27 for VITROS 4600 CHEMISTRY SYSTEM 6802445 manufactured by Ortho-clinical Diagnostics.
[78957281]
The investigation determined that a higher than expected valp result was obtained from a vitros performance verifier quality control fluid processed using vitros valp reagent with a vitros 4600 chemistry system. There is no indication a reagent issue contributed to the event. The most likely assignable cause is instrument related. The results of pre-service within-run precision testing demonstrated that the vitros system was not operating as expected at the time of the event. An ortho field engineer performed service actions to adjust the cuvette incubator & metering trucks and clean residue from the read channel. The valp quality control results obtained after service indicate acceptable performance has been maintained.
Patient Sequence No: 1, Text Type: N, H10
[78957282]
A customer obtained a higher than expected valproic acid (valp) result from a vitros performance verifier quality control fluid (lot d5002= 134. 2 vs. Expected 111. 5 ug/ml) using vitros valp reagent in combination with a vitros 4600 chemistry 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 higher than expected valp result was generated from a non-patient fluid, 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 1913621 / ivd 407462.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319681-2017-00049 |
| MDR Report Key | 6671494 |
| Date Received | 2017-06-27 |
| Date of Report | 2017-06-27 |
| Date of Event | 2017-06-07 |
| Date Mfgr Received | 2017-06-09 |
| Device Manufacturer Date | 2012-07-26 |
| Date Added to Maude | 2017-06-27 |
| 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 4600 CHEMISTRY SYSTEM |
| Generic Name | CHEMISTRY ANALYZER |
| Product Code | LEG |
| Date Received | 2017-06-27 |
| Catalog Number | 6802445 |
| 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 4600 CHEMISTRY SYSTEM |
| Generic Name | CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-06-27 |
| Catalog Number | 6802445 |
| 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 | 2017-06-27 |