MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-08 for VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 1662659 manufactured by Ortho-clinical Diagnostics.
[117014293]
The investigation determined that a lower than expected vitros na+ result was obtained when performing a patient sample correlation on a vitros 4600 chemistry system. The likely cause of lower than expected vitros na+ result is a suboptimal calibration. However, the cause of the suboptimal calibration could not be definitively determined. A diagnostic within run vitros na+ precision test was not performed to evaluate the performance of the vitros 4600 system, therefore, the vitros 4600 system could not be entirely ruled out as a contributor of the event. As vitros na+ lot 4219-0991-0597 had not been put into use, historical vitros na+ quality control results were not available to evaluate the performance of vitros na+ lot 4219-0991-0597. Therefore an issue with the reagent could not be entirely ruled out as a contributor of the event. The lower than expected vitros na+ result was likely caused by a suboptimal calibration event on (b)(6) 2018 likely due to a calibrator handling issue. Acceptable performance was observed using freshly prepared calibrators without altering the condition of the vitros 4600 system. This would indicate that both vitros na+ lot 4219-0991-0597 and the vitros 4600 system did not contribute to the suboptimal calibration.
Patient Sequence No: 1, Text Type: N, H10
[117014294]
A customer obtained a lower than expected vitros sodium (na+) result when performing a patient sample correlation on a vitros 4600 chemistry system. Patient sample 20 vitros na+ result 144 mmol/l versus the expected vitros na+ result 151 mmol/l. Biased results of the magnitude and direction observed may lead to inappropriate physician action if the event were to occur undetected. The lower than expected na+ result was obtained while performing a patient sample correlation and was not reported outside of the laboratory. However the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2018-00022 |
| MDR Report Key | 7764842 |
| Date Received | 2018-08-08 |
| Date of Report | 2018-08-08 |
| Date of Event | 2018-07-16 |
| Date Mfgr Received | 2018-07-16 |
| Device Manufacturer Date | 2017-05-22 |
| Date Added to Maude | 2018-08-08 |
| 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 | 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 | 1000 LEE ROAD |
| Manufacturer City | ROCHESTER NY 14606 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14606 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | JIX |
| Date Received | 2018-08-08 |
| Catalog Number | 1662659 |
| Lot Number | 0267 |
| Device Expiration Date | 2019-05-22 |
| 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 | 2018-08-08 |