MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-15 for VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 1662659 manufactured by Ortho-clinical Diagnostics.
[87469884]
The investigation determined that higher than expected vitros na+ results were obtained from a single non-vitros biorad l1 quality control fluid, lot 31820, using vitros na+ slides on a vitros 4600 chemistry system. The event was isolated to the calibration event performed on 19 august 2017. In addition to the vitros na+ assay, the vitros k+ and cl- assays were also affected. The calibrations were suboptimal when compared to the typical calibration responses and parameters. The most likely cause of the suboptimal 19 august calibrations was user error, where the reconstituted calibrators (calibrator kit 257) were stored for too long at room temperature prior to use. Acceptable vitros na+ performance was observed after a recalibration event was performed using properly handled calibrator fluids. The investigation found no indication the vitros 4600 chemistry system or vitros na+ slide lot contributed to the event.
Patient Sequence No: 1, Text Type: N, H10
[87469885]
The investigation determined that higher than expected vitros na+ results were obtained from a single non-vitros biorad l1 quality control fluid, lot 31820, using vitros na+ slides on a vitros 4600 chemistry system. Biorad l1 na+ results of 138. 9, and 142. 7 mmol/l vs. The expected result of 126. 0 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. A review of vitros na+ results during the timeframe of the event determined that two patient samples were affected and higher than expected results were reported outside of the laboratory. However, corrected reports were issued and there were no allegations of patient harm as a result of this event. This report corresponds to ortho clinical diagnostics inc. Complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2017-00015 |
| MDR Report Key | 6870639 |
| Date Received | 2017-09-15 |
| Date of Report | 2017-09-15 |
| Date of Event | 2017-08-19 |
| Date Mfgr Received | 2017-08-20 |
| Device Manufacturer Date | 2017-04-17 |
| Date Added to Maude | 2017-09-15 |
| 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 |
| 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 | 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 | 2017-09-15 |
| Catalog Number | 1662659 |
| Lot Number | 257 |
| ID Number | 10758750009503 |
| Device Expiration Date | 2018-12-19 |
| 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 | 2017-09-15 |