MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05 report with the FDA on 2015-03-30 for VITROS 350 CHEMISTRY SYSTEM 6802153 manufactured by Ortho-clinical Diagnostics.
[5753787]
The customer complained that lower and higher than expected vitros amon results were obtained from two different levels of vitros lpv fluids tested on a vitros 350 chemistry system. Vitros lpv m3575 results: 92 and 100 umol/l vs expected result 45. 1 umol/l. Vitros lpv n3576 results: 142. 4, 147. 5, 143. 8, 136. 2, 142. 4, and 142. 9 umol/l vs expected result 199. 2 umol/l. Biased results of the direction and magnitude observed may lead to inappropriate physician action. Patient samples were processed with the vitros amon assay over the time frame of the event; though no reported patient results had been in question. However, the investigation cannot conclude that patient sample results were not affected or would not be affected if the event were to recur undetected. There was no reported allegation of patient harm as a result of this event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[13080872]
The investigation determined that lower and higher than expected vitros amon results were obtained from two different levels of vitros lpv fluids tested on a vitros 350 chemistry system. The assignable cause of the event is most likely an instrument event related to microslide incubator contamination. The cause of the amon contamination of the micro slide incubator was most likely caused by user error, where ammonia-based cleaning fluids were used in the laboratory. Results of precision testing demonstrated that the vitros 350 chemistry system was not operating as expected at the time of the event. Following service actions and recalibration of the assay, acceptable vitros amon performance was obtained.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319681-2015-00036 |
| MDR Report Key | 4640513 |
| Report Source | 00,01,05 |
| Date Received | 2015-03-30 |
| Date of Report | 2015-03-30 |
| Date of Event | 2014-12-14 |
| Date Mfgr Received | 2015-03-02 |
| Device Manufacturer Date | 2008-04-08 |
| Date Added to Maude | 2015-05-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 350 CHEMISTRY SYSTEM |
| Generic Name | CHEMISTRY ANALYZER |
| Product Code | JIF |
| Date Received | 2015-03-30 |
| Catalog Number | 6802153 |
| 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 | 2015-03-30 |