MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-27 for VITROS CHEMISTRY PRODUCTS CALIBRATORY KIT 2 1662659 manufactured by Ortho-clinical Diagnostics.
[68972186]
The investigation determined that a higher than expected vitros k+ result was obtained on a vitros 5600 integrated system. The event was isolated to the calibration event performed on (b)(6) 2017. The calibration was suboptimal as shown by the high recovery of the post calibration quality control results. The most likely cause of the suboptimal (b)(6) calibration was user error, where the calibrator lyophilate was reconstituted with an incorrect volume of diluent, however, this could not be confirmed. There was no evidence that the vitros 5600 integrated system or vitros k+ malfunctioned.
Patient Sequence No: 1, Text Type: N, H10
[68972187]
A customer obtained a higher than expected vitros k+ result when testing a quality control fluid on a vitros 5600 integrated system. Vitros k+ result 7. 24 mmol/l vs. Expected vitros k+ result 2. 89 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 k+ result was generated from testing a quality control fluid. Patient results were also affected, however the magnitude of the bias did not constitute a potential health and safety event, and no action was taken by the physician due to the reported results. There were no allegation of patient harm as a result of this event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2017-00005 |
| MDR Report Key | 6362696 |
| Date Received | 2017-02-27 |
| Date of Report | 2017-02-27 |
| Date of Event | 2017-01-30 |
| Date Mfgr Received | 2017-02-03 |
| Device Manufacturer Date | 2016-08-11 |
| Date Added to Maude | 2017-02-27 |
| 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 CALIBRATORY KIT 2 |
| Generic Name | IN VITRO DIAGNOSTIC |
| Product Code | JIX |
| Date Received | 2017-02-27 |
| Catalog Number | 1662659 |
| Lot Number | 0226 |
| ID Number | 10758750009503 |
| Device Expiration Date | 2018-07-18 |
| 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 | 2017-02-27 |