MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-08 for VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 1662659 manufactured by Ortho-clinical Diagnostics.
[133935270]
The investigation determined that higher than expected vitros na+ and vitros k+ results were attained from a non-vitros quality control (qc) fluid processed using vitros chemistry products na+ slides and vitros chemistry products k+ slides in combination with a vitros 5600 integrated system. The event was isolated to the calibration event performed on (b)(6) 2018. The calibrations were suboptimal when compared to the typical calibration responses and parameters, and as shown by the high recovery of the post calibration quality control results. The vitros calibration kit in use for both calibration events was vitros cal kit 267. The most likely cause of the suboptimal calibration is user error, where improper reconstitution of calibrators or improper sample handling occurred, although this could not be confirmed. Acceptable vitros na+ and k+ performance was observed after additional calibration events were performed using properly handled calibrator fluids. The investigation found no indication that the vitros 5600 integrated system or vitros na+ slide lot 4219-0990-0261 or vitros k+ slide lot 4102-0991-8560 contributed to the event.
Patient Sequence No: 1, Text Type: N, H10
[133935271]
A customer obtained higher than expected vitros na+ and vitros k+ results from a non-vitros quality control (qc) fluid processed using vitros chemistry products na+ slides and vitros chemistry products k+ slides in combination with a vitros 5600 integrated system. Biorad l1 na+ result of 194. 8 mmol/l vs. The expected result of 120. 0 mmol/l. Biorad l1 k+ result of 4. 50 mmol/l vs. The expected result of 2. 55 mmol/l. 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 vitros na+ and vitros k+ results were obtained from a qc fluid and were not reported from the laboratory. There were no allegations of patient harm as a result of the event. This report corresponds to ortho clinical diagnostics inc. Complaint numbers (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2019-00001 |
| MDR Report Key | 8229217 |
| Date Received | 2019-01-08 |
| Date of Report | 2019-01-08 |
| Date of Event | 2018-12-10 |
| Date Mfgr Received | 2018-12-12 |
| Device Manufacturer Date | 2017-07-18 |
| Date Added to Maude | 2019-01-08 |
| 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 DIAGNOSTICS |
| Product Code | JIX |
| Date Received | 2019-01-08 |
| 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 | 2019-01-08 |